GEMCITABINE 38 MG/ML POWDER FOR SOLUTION FOR INFUSION
Active substance: GEMCITABINE HYDROCHLORIDE
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Gemcitabine 38 mg/ml Package Insert - UK (Bordon)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Gemcitabine 38 mg/ml powder for solution for infusion Gemcitabine
Read all of this leaflet carefully before you start receiving this medicine. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor, nurse or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. In this leaflet: 1. What Gemcitabine is and what it is used for 2. Before you are given Gemcitabine 3. How Gemcitabine is given 4. Possible side effects 5. How to store Gemcitabine 6. Further information 1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR Gemcitabine belongs to a group of medicines called cytotoxics. These medicines kill dividing cells, including cancer cells. Gemcitabine may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer. Gemcitabine is used in the treatment of the following types of cancer: non-small cell lung cancer (NSCLC), alone or together with cisplatin. pancreatic cancer. breast cancer, together with paclitaxel. ovarian cancer, together with carboplatin. bladder cancer, together with cisplatin. 2. BEFORE YOU ARE GIVEN GEMCITABINE You should not be given Gemcitabine: - if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine. - if you are breast-feeding. Take special care with Gemcitabine: Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function. Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemcitabine. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. Periodically you will have samples of your blood taken to evaluate your kidney and liver function. Please tell your doctor if: you have, or have previously had liver disease, heart disease or vascular disease. you have recently had, or are going to have radiotherapy. you have been vaccinated recently you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney failure). Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine. If you would like to father a child during the treatment or in the 6 months following treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy. Taking other medicines Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemcitabine should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine during pregnancy. If you are breast-feeding, tell your doctor. You must discontinue breast-feeding during Gemcitabine treatment. Driving and using machines Gemcitabine may make you feel sleepy, particularly if you have consumed any alcohol. Do not drive a car or use machinery until you are sure that Gemcitabine treatment has not made you feel sleepy. Important information about some of the ingredients of Gemcitabine Gemcitabine contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial, and 17.5 mg (< 1 mmol) sodium in each 1000 mg vial and 35 mg (1.5 mmol) sodium in each 2000 mg vial. To be taken into consideration by patients on a controlled sodium diet. 3. HOW GEMCITABINE IS GIVEN The usual dose of Gemcitabine is 1000-1250 mg for every square metre of your body's surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition. How frequently you receive your Gemcitabine infusion depends on the type of cancer that you are being treated for. A hospital pharmacist or doctor will have dissolved the Gemcitabine powder before it is given to you. You will always receive Gemcitabine by infusion into one of your veins. The infusion will last approximately 30 minutes. If you have further questions on the use of this product ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Gemcitabine can cause side effects, although not everybody gets them. Frequencies of the observed side effects are defined as: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency can't be estimated from the available data You must contact your doctor immediately if you notice any of the following: Fever or infection (common): if you have a temperature of 38C or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common). Irregular heart rate (arrhythmia) (frequency not known). Pain, redness, swelling or sores in your mouth (common). Allergic reactions: if you develop skin rash (very common) / itching (common), or fever (very common). Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common). Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common). Difficulty breathing (it is very common to have mild breathing difficulty soon after the Gemcitabine infusion which soon passes, however uncommonly or rarely there can be more severe lung problems) Side effects with Gemcitabine may include: Very common side effects Low haemoglobin level (anaemia) Low white blood cells Low platelet count Difficulty breathing Vomiting Nausea Skin rash- allergic skin rash, frequently itchy Hair loss Liver problems: found through abnormal blood test results Blood in urine Abnormal urine tests: protein in urine Flu like symptoms including fever Oedema (swelling of ankles, fingers, feet, face) Common side effects Fever accompanied by low white blood cell count (febrile neutropaenia) Anorexia (poor appetite) Headache Insomnia Sleepiness Cough Runny nose Constipation Diarrhoea The following information is intended for medical or healthcare professionals only: Instructions for use, handling and disposal. 1. Use aseptic techniques during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration. 2. Calculate the dose and the number of Gemcitabine vials needed. 3. Reconstitute the 200 mg vials with 5 ml of 9 mg/ml (0.9 %) sterile sodium chloride solution for injection, without preservative, the 1000 mg vial with 25 ml sterile sodium chloride solution for injection, without preservative and the 2000 mg vial with 50 ml sterile sodium chloride solution for injection, without preservative. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial), 26.3 ml (1000 mg vial) or 52.6 ml (2000 mg vial) respectively. This dilution yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder. Further dilution with sterile sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative may be done. The resulting solution is clear and ranges in colour from colourless to light strawcoloured. 4. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer. 5. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur. Chemical and physical in-use stability has been demonstrated for 24 hours at 25C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior
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Font & Size: Arial 8 Pt.
Date: 12 Nov 2010
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Dimension: 592 x 132 mm
D:\Europe\Gemita\UK\Bordon\Gecit-PIL 38mg-ml.cdr
Gemcitabine 38 mg/ml Package Insert - UK (Bordon)
to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless reconstitution has taken place in controlled and validated aseptic conditions. 6. Chemical and physical in-use stability for the diluted injection has been demonstrated for 30 days at 25C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless dilution has taken place in controlled and validated aseptic conditions. 7. Gemcitabine solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements. Preparation and administration precautions The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Handling of the solution for infusion should be done in a safety box and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses. If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be consulted. If the solution is spilled on the skin, rinse thoroughly with water. Disposal Any unused product should be disposed of in accordance with local requirements. Pain, redness, swelling or sores in the mouth Itching Sweating Muscle pain Back pain Fever Weakness Chills Uncommon side effects Interstitial pneumonitis (scarring of the air sacs of the lung) Spasm of the airways (wheeze) Abnormal chest X ray/scan (scarring of the lungs) Rare side effects Heart attack (myocardial infarction) Low blood pressure Skin scaling, ulceration or blister formation Injection site reactions Very rare side effects Increased platelet count Anaphylactic reaction (severe hypersensitivity/ allergic reaction) Sloughing of skin and severe skin blistering Side effects with frequency not known Irregular heart beat (arrhythmia) Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure) Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy. Fluid in the lungs Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply) Heart failure Kidney failure Gangrene of fingers or toes Serious liver damage, including liver failure Stroke You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects. If you are concerned about any side effects, talk to your doctor. If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor. 5. HOW TO STORE GEMCITABINE Keep out of the reach and sight of children. Do not use Gemcitabine powder for solution for infusion after the expiry date which is stated on the carton and label after. The expiry date refers to the last day of that month. The unopened vial does not require any special storage conditions. Reconstituted solution: The product should be used immediately. When prepared as directed, chemical and physical in-use stability of reconstituted solutions of gemcitabine were demonstrated for 24 hours at 25C. Further dilution by a healthcare provider may be done. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur. Diluted solution: The chemical and physical in-use stability of diluted solutions of gemcitabine was demonstrated for 30 days at 25C. Do not use Gemcitabine powder for solution for infusion if you notice any particulate matter and / or discolouration. This medicine is for single use only; any unused solution should be discarded under the local requirements. 6. FURTHER INFORMATION What Gemcitabine contains The active substance is gemcitabine. Each vial contains 200, 1000 or 2000 mg of gemcitabine (as gemcitabine hydrochloride). The other ingredients are mannitol (E421), sodium acetate trihydrate, hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment). What Gemcitabine looks like and contents of the pack Gemcitabine is a white to off-white powder, for solution for infusion in a vial. Each vial contains 200, 1000 or 2000 mg of gemcitabine. Each pack of Gemcitabine contains 1 vial. Marketing Authorisation Holder and Manufacturer Fresenius Kabi Oncology Plc. Lion Court, Farnham Road, Bordon Hampshire, GU35 0NF, United Kingdom This medicinal product is authorised in the Member States of the EEA under the following names: Belgium: Gemcitabine Fresenius Kabi 38 mg/ml poeder voor oplossing voor infusie Cyprus: Kabi 38 mg/ml Germany: Gemcitabin Kabi 38 mg/ml Pulver zur Herstellung einer Infusionslsung Spain: Gemcitabina Kabi 200 mg polvo para solucin para perfusion EFG Gemcitabina Kabi 1000 mg polvo para solucin para perfusion EFG Gemcitabina Kabi 2000 mg polvo para solucin para perfusion Gemcitabin Fresenius Kabi 200 mg infuusiokuiva-aine, liuosta varten Gemcitabin Fresenius Kabi 1000 mg infuusiokuiva-aine, liuosta varten Gemcitabin Fresenius Kabi 2000 mg infuusiokuiva-aine, liuosta varten France: Gemcitabine Kabi 38 mg/ml, poudre pour solution pour perfusion Hungary: Gemcitabin Kabi 38 mg/ml por oldatos infzihoz Ireland: Gemcitabine 200 mg powder for solution for infusion Gemcitabine 1 g powder for solution for infusion Gemcitabine 2 g powder for solution for infusion Italy: Gemcitabina Kabi 38 mg/ml polvere per soluzione per infusione Luxemburg: Gemcitabin Kabi 38 mg/ml Pulver zur Herstellung einer Infusionslsung Sweden: Gemcitabin Fresenius Kabi 200 mg pulver till infusionsvtska, lsning Gemcitabin Fresenius Kabi 1000 mg pulver till infusionsvtska, lsning Gemcitabin Fresenius Kabi 2000 mg pulver till infusionsvtska, lsning Slovenia: Gemcitabin Kabi 38 mg/ml praek za raztopino za infundiranje United Kingdom: Gemcitabine 38 mg/ml powder for solution for infusion This leaflet was last approved in January 2010
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Date: 12 Nov 2010
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D:\Europe\Gemita\UK\Bordon\Gecit-PIL 38mg-ml.cdr
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Gemcitabine 38 mg/ml powder for solution for infusion Gemcitabine
Read all of this leaflet carefully before you start receiving this medicine. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor, nurse or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. In this leaflet: 1. What Gemcitabine is and what it is used for 2. Before you are given Gemcitabine 3. How Gemcitabine is given 4. Possible side effects 5. How to store Gemcitabine 6. Further information 1. WHAT GEMCITABINE IS AND WHAT IT IS USED FOR Gemcitabine belongs to a group of medicines called cytotoxics. These medicines kill dividing cells, including cancer cells. Gemcitabine may be given alone or in combination with other anti-cancer medicines, depending on the type of cancer. Gemcitabine is used in the treatment of the following types of cancer: non-small cell lung cancer (NSCLC), alone or together with cisplatin. pancreatic cancer. breast cancer, together with paclitaxel. ovarian cancer, together with carboplatin. bladder cancer, together with cisplatin. 2. BEFORE YOU ARE GIVEN GEMCITABINE You should not be given Gemcitabine: - if you are allergic (hypersensitive) to gemcitabine or any of the other ingredients of Gemcitabine. - if you are breast-feeding. Take special care with Gemcitabine: Before the first infusion you will have samples of your blood taken to evaluate if you have sufficient kidney and liver function. Before each infusion you will have samples of your blood taken to evaluate if you have enough blood cells to receive Gemcitabine. Your doctor may decide to change the dose or delay treating you depending on your general condition and if your blood cell counts are too low. Periodically you will have samples of your blood taken to evaluate your kidney and liver function. Please tell your doctor if: you have, or have previously had liver disease, heart disease or vascular disease. you have recently had, or are going to have radiotherapy. you have been vaccinated recently you develop breathing difficulties or feel very weak and are very pale (may be a sign of kidney failure). Men are advised not to father a child during and up to 6 months following treatment with Gemcitabine. If you would like to father a child during the treatment or in the 6 months following treatment, seek advice from your doctor or pharmacist. You may want to seek counselling on sperm storage before starting your therapy. Taking other medicines Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including vaccinations and medicines obtained without a prescription. Pregnancy and breast-feeding If you are pregnant, or thinking about becoming pregnant, tell your doctor. The use of Gemcitabine should be avoided during pregnancy. Your doctor will discuss with you the potential risk of taking Gemcitabine during pregnancy. If you are breast-feeding, tell your doctor. You must discontinue breast-feeding during Gemcitabine treatment. Driving and using machines Gemcitabine may make you feel sleepy, particularly if you have consumed any alcohol. Do not drive a car or use machinery until you are sure that Gemcitabine treatment has not made you feel sleepy. Important information about some of the ingredients of Gemcitabine Gemcitabine contains 3.5 mg (< 1 mmol) of sodium in each 200 mg vial, and 17.5 mg (< 1 mmol) sodium in each 1000 mg vial and 35 mg (1.5 mmol) sodium in each 2000 mg vial. To be taken into consideration by patients on a controlled sodium diet. 3. HOW GEMCITABINE IS GIVEN The usual dose of Gemcitabine is 1000-1250 mg for every square metre of your body's surface area. Your height and weight are measured to work out the surface area of your body. Your doctor will use this body surface area to work out the right dose for you. This dosage may be adjusted, or treatment may be delayed depending on your blood cell counts and on your general condition. How frequently you receive your Gemcitabine infusion depends on the type of cancer that you are being treated for. A hospital pharmacist or doctor will have dissolved the Gemcitabine powder before it is given to you. You will always receive Gemcitabine by infusion into one of your veins. The infusion will last approximately 30 minutes. If you have further questions on the use of this product ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Gemcitabine can cause side effects, although not everybody gets them. Frequencies of the observed side effects are defined as: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency can't be estimated from the available data You must contact your doctor immediately if you notice any of the following: Fever or infection (common): if you have a temperature of 38C or greater, sweating or other signs of infection (since you might have less white blood cells than normal which is very common). Irregular heart rate (arrhythmia) (frequency not known). Pain, redness, swelling or sores in your mouth (common). Allergic reactions: if you develop skin rash (very common) / itching (common), or fever (very common). Tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common). Bleeding from the gums, nose or mouth or any bleeding that would not stop, reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common). Difficulty breathing (it is very common to have mild breathing difficulty soon after the Gemcitabine infusion which soon passes, however uncommonly or rarely there can be more severe lung problems) Side effects with Gemcitabine may include: Very common side effects Low haemoglobin level (anaemia) Low white blood cells Low platelet count Difficulty breathing Vomiting Nausea Skin rash- allergic skin rash, frequently itchy Hair loss Liver problems: found through abnormal blood test results Blood in urine Abnormal urine tests: protein in urine Flu like symptoms including fever Oedema (swelling of ankles, fingers, feet, face) Common side effects Fever accompanied by low white blood cell count (febrile neutropaenia) Anorexia (poor appetite) Headache Insomnia Sleepiness Cough Runny nose Constipation Diarrhoea The following information is intended for medical or healthcare professionals only: Instructions for use, handling and disposal. 1. Use aseptic techniques during the reconstitution and any further dilution of gemcitabine for intravenous infusion administration. 2. Calculate the dose and the number of Gemcitabine vials needed. 3. Reconstitute the 200 mg vials with 5 ml of 9 mg/ml (0.9 %) sterile sodium chloride solution for injection, without preservative, the 1000 mg vial with 25 ml sterile sodium chloride solution for injection, without preservative and the 2000 mg vial with 50 ml sterile sodium chloride solution for injection, without preservative. Shake to dissolve. The total volume after reconstitution is 5.26 ml (200 mg vial), 26.3 ml (1000 mg vial) or 52.6 ml (2000 mg vial) respectively. This dilution yields a gemcitabine concentration of 38 mg/ml, which includes accounting for the displacement volume of the lyophilised powder. Further dilution with sterile sodium chloride 9 mg/ml (0.9%) solution for injection, without preservative may be done. The resulting solution is clear and ranges in colour from colourless to light strawcoloured. 4. Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer. 5. Solutions of reconstituted gemcitabine should not be refrigerated, as crystallisation may occur. Chemical and physical in-use stability has been demonstrated for 24 hours at 25C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior
Black
Font & Size: Arial 8 Pt.
Date: 12 Nov 2010
Version: 01
xxxxxx
xxxxxxxxxx
Dimension: 592 x 132 mm
D:\Europe\Gemita\UK\Bordon\Gecit-PIL 38mg-ml.cdr
Gemcitabine 38 mg/ml Package Insert - UK (Bordon)
to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless reconstitution has taken place in controlled and validated aseptic conditions. 6. Chemical and physical in-use stability for the diluted injection has been demonstrated for 30 days at 25C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at room temperature, unless dilution has taken place in controlled and validated aseptic conditions. 7. Gemcitabine solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements. Preparation and administration precautions The normal safety precautions for cytostatic agents must be observed when preparing and disposing of the infusion solution. Handling of the solution for infusion should be done in a safety box and protective coats and gloves should be used. If no safety box is available, the equipment should be supplemented with a mask and protective glasses. If the preparation comes into contact with the eyes, this may cause serious irritation. The eyes should be rinsed immediately and thoroughly with water. If there is lasting irritation, a doctor should be consulted. If the solution is spilled on the skin, rinse thoroughly with water. Disposal Any unused product should be disposed of in accordance with local requirements. Pain, redness, swelling or sores in the mouth Itching Sweating Muscle pain Back pain Fever Weakness Chills Uncommon side effects Interstitial pneumonitis (scarring of the air sacs of the lung) Spasm of the airways (wheeze) Abnormal chest X ray/scan (scarring of the lungs) Rare side effects Heart attack (myocardial infarction) Low blood pressure Skin scaling, ulceration or blister formation Injection site reactions Very rare side effects Increased platelet count Anaphylactic reaction (severe hypersensitivity/ allergic reaction) Sloughing of skin and severe skin blistering Side effects with frequency not known Irregular heart beat (arrhythmia) Adult Respiratory Distress Syndrome (severe lung inflammation causing respiratory failure) Radiation recall-(a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy. Fluid in the lungs Radiation toxicity- scarring of the air sacs of the lung associated with radiation therapy Ischaemic colitis (inflammation of the lining of the large bowel, caused by reduced blood supply) Heart failure Kidney failure Gangrene of fingers or toes Serious liver damage, including liver failure Stroke You might have any of these symptoms and/or conditions. You must tell your doctor as soon as possible when you start experiencing any of these side effects. If you are concerned about any side effects, talk to your doctor. If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor. 5. HOW TO STORE GEMCITABINE Keep out of the reach and sight of children. Do not use Gemcitabine powder for solution for infusion after the expiry date which is stated on the carton and label after
xxxxxxxxxx
Finland:
Black
Font & Size: Arial 8 Pt.
Date: 12 Nov 2010
Version: 01
Dimension: 592 x 132 mm
D:\Europe\Gemita\UK\Bordon\Gecit-PIL 38mg-ml.cdr
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Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
