PARMID XL 10MG PROLONGED RELEASE TABLETS
Active substance: FELODIPINE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Felodipine
Parmid XL 5 mg and 10 mg Prolonged Release Tablets
SZ00000LT000
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.
What is in this leaflet: 1. What Parmid XL is and what it is used for 2. What you need to know before you take Parmid XL 3. How to take Parmid XL 4. Possible side effects 5. How to store Parmid XL 6. Content of the pack and other information
Parmid XL belongs to a group of medicines called calcium antagonists. These medicines alleviate high blood pressure by dilating the small blood vessels (the arteries) and facilitate the hearts pumping work.
Parmid XL is used in the treatment of high blood pressure.
1 2
What Parmid XL is and what it is used for
Take special care with Parmid XL Talk to your doctor before taking Parmid XL, if you have any or have had any medical condition especially the following: conduction disturbances in the heart heart failure which is in a stable condition increased heart beat rate if the heart valves of your left heart chamber are constricted mild to moderate reduced liver function severe renal failure atrioventricular conduction disturbances of 2nd or 3rd degree. If treatment with Parmid XL is discontinued abruptly, a hypertensive crisis may occur in individual cases.
Do not take Parmid XL if you are allergic to felodipine, or any of the other ingredients of this medicine (listed in section 6) or similar calcium channel blockers (the so-called dihydropyridine derivates). if you are suffering from insufficient blood supply to your tissues with symptoms like e.g. low blood pressure, low pulse, fast heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart troubles. if you have severe narrowing (stenosis) of the aorta or of the heart valves (mitral or aortic valve). if you suffer from an enlarged heart muscle (hypertrophic cardiomyopathy). if you have had a heart attack, i.e. a blood clot in the heart, within the last 2 months. if you get heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris). if you suffer from a heart failure which was not stabilised by medical measures (decompensated heart failure). if you have any other severe heart disease (e.g. severe heart failure, heart muscle disease or severe valvular disorder). if you have a severe liver disease. if you are pregnant.
What you need to know before you take Parmid XL
Medicines that can reduce the amount of felodipine in the blood: Phenytoin or carbamazepine (medicines for epilepsy) Barbiturates (tranquillising agents and medicines used in the treatment of epilepsy) Rifampicin (antibiotic) Natural remedies containing extract of St. Johns wort (Hypericum perforatum).
Medicines that can increase the amount of felodipine in the blood: Cimetidine (a medicine for stomach ulcers) Certain antibiotics such as erythromycin or telithromycin (antibiotics) Ketoconazole or itraconazole (fungicidal agents) HIV protease inhibitors (antiviral medicines to treat HIV infections, e.g. ritonavir).
Certain other medicines can affect or be affected by Parmid XL. Some of these medicines are: Cyclosporin, tacrolimus (medicines used after organ transplants) Digoxin (medicinal products to strengthen cardiac power).
Medicines that can increase the effect of felodipine: Other medicines used in the treatment of high blood pressure, e.g. beta-blockers, ACE-inhibitors and diuretics Medicine to treat depressions (tricyclic antidepressants) Hydrochlorothiazide (diuretic agent). Parmid XL can enhance low potassium levels in the blood when taken together with water tablets (diuretics).
Parmid XL with food and drink Simultaneous intake of grapefruit or grapefruit juice has influence on the effect of Parmid XL. Pregnancy and breast-feeding Do not take Parmid XL if you are pregnant. Pregnancy must be excluded before starting treatment with Parmid XL. The use of Parmid XL is not recommended in women who are breast-feeding.
The concomitant intake of grapefruit juice should be avoided.
If you are unsure if any of the above apply to you, please discuss this with your doctor. Other medicines and Parmid XL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
As with other vasodilators, Parmid XL may, in rare cases, precipitate significant low blood pressure with fast heart beat (tachycardia) which in susceptible individuals may result in insufficient blood supply of the heart (myocardial ischaemia). This may lead to a heart attack.
Parmid XL contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Driving and using machines Because of individual variability, the ability to react can be so altered that the ability to drive or operate machinery or work in an unsupported position can be impaired. This applies especially at the start of treatment, when the dosage is increased, when the preparation is changed and in conjunction with alcohol.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Always take this medicine for as long and exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Continued on the next page >>
3
How to take Parmid XL
Artwork Proof Box
A healthy decision Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom. T: 01276 698020 F: 01276 698324 W: www.uk.sandoz.com E: sandoz.artwork@me.com
Ref: V048 product harmonisation + V050 (Nat. phase) Proof no. 005.1 RA Approved? Yes Colours: Black Black 20% Dimensions: 148 x 270 mm Artwork/RA Checklist: Product name Strength/dosage Pack size PL number Storage Date prepared: 21/01/2013 Date approved: 21/01/2013 Prepared by: TB Approved by: MS Fonts: Helvetica Font size: 7pt Warnings Excipients Braille
PROPOSED
MOCK UP
Parmid XL should be taken once daily. Take the tablets whole and not chewed or crushed with a glass of water. The tablets may be taken on empty stomach or with a light meal, however a high-fat meal should be avoided. The recommended dose is: If you are taking Parmid XL for high blood pressure, the recommended starting dose is 5 mg once daily. If necessary, your doctor may increase the dose to 10 mg once daily. The maximum daily dose is 10 mg Parmid XL. Children and adolescents, under 18 years The use of Parmid XL is not recommended in children. The tablets are not intended to be broken.
Elderly patients The recommended initial dose should be adapted in the elderly. Impaired liver or kidney function The dose should be adjusted according to the doctors prescription.
The person concerned should lie down with his/her arms and legs up (resting on a couple of cushions, for example). Symptoms of an overdose are: extreme dizziness and/or feeling very light-headed, caused by very low blood pressure, problems with breathing, having to urinate very often. If you forget to take Parmid XL Take the missed dose as soon as you remember but never take two doses in one day.
If you take more Parmid XL than you should Contact your doctor or the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so that people will know what you have taken.
Very rare (affects less than 1 out of 10,000 people) Disturbances of liver function (elevated transaminase values) Fever Photosensitivity Inflammation in the blood vessels caused by the white blood cells (Leucocytoclastic vasculitis) Enlarged breasts in men Heart attack Abnormally heavy menstruation Inflammation and swelling of the gums, which can be avoided or reduced by good oral hygiene Increased need to urinate. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Rare (affects less than 1 out of 1,000 people) Nettle rash Fainting Vomiting Muscle pain, joint pain Erection disorders.
Uncontrolled shaking Gastro-intestinal complaints (e.g. nausea, vomiting, diarrhoea, constipation) Weight gain Sweating Prickling and tingling sensation of the skin.
Keep out of the sight and reach of children.
5
How to store Parmid XL
If you stop taking Parmid XL Your doctor has told you how long you should take Parmid XL. If you stop the treatment suddenly, your symptoms may come back. Do not stop the treatment earlier than agreed without discussing this with your doctor. Parmid XL is usually used for long-term treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Do not use Parmid XL after the expiry date EXP which is stated on the packaging. The expiry date refers to the last day of that month. Do not store above 25 C. Shelf life in blisters: 4 years.
Contact an emergency room or a doctor immediately if the following side effects occur: Allergic reaction with swelling of the skin of face or extremities, swelling of lips or tongue, swelling of the mucous membranes in the mouth and throat, resulting in shortness of breath and difficulty to swallow (angioedema). Contact an emergency room or a doctor immediately if this occurs. In isolated cases severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis) have been observed. Other possible side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
4
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Possible side effects
What Parmid XL looks like and contents of the pack: Parmid XL 5 mg Tablets are round, pale red to grey-red, biconvex film-coated tablet with embossment F5. Parmid XL 10 mg Tablets are round, pale red to grey-red, biconvex film-coated tablet with embossment F10. Your tablets come in original packs of 10, 20, 28, 30, 50, 56, 100 or 100 x 1 prolonged release tablets. Marketing Authorisation Holder: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. Not all pack sizes may be marketed.
What Parmid XL contains The active substance is felodipine. One prolonged release tablet contains 5 mg or 10 mg of felodipine. The other ingredients are: lactose monohydrate, microcrystalline cellulose, hydroxypropylmethylcellulose, magnesium stearate, sodium lauryl sulphate, macrogol 4000, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
6
Contents of the pack and other information
Very common (affects more than 1 out of 10 people) Tinnitus (ringing or buzzing in the ears) can occur, especially at the beginning of treatment, when the dose is increased or if high doses are administered. In general these reactions disappear as the treatment continues Peripheral oedema (the degree of ankle swelling is depends on the dose) Particularly at the beginning of treatment, angina pectoris attacks may occur. In patients with pre-existing angina pectoris there may be an increase in the frequency, duration and severity of the attacks. Common (affects less than 1 out of 10 people) Flushing, headache (especially at the beginning of treatment, when the dose is increased or when high doses are administered). In general these reactions disappear as the treatment continues. Uncommon (affects less than 1 out of 100 people) Dizziness Fatigue Low blood pressure A quicker or irregular heart beat Increased heart rate and breathing difficulties Restlessness Pins and needles
Manufacter: Salutas Pharma GmbH, Otto-von-Guericke-Allee 139179, Barleben, Germany Salutas Pharma GmbH, Dieselstrasse 5D-70839, Gerlingen, Germany. or
This leaflet was last revised in 01/2013.
SZ00000LT000
Artwork Proof Box
A healthy decision Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom. T: 01276 698020 F: 01276 698324 W: www.uk.sandoz.com E: sandoz.artwork@me.com
Ref: V048 product harmonisation + V050 (Nat. phase) Proof no. 005.1 RA Approved? Yes Colours: Black Black 20% Dimensions: 148 x 270 mm Artwork/RA Checklist: Product name Strength/dosage Pack size PL number Storage Date prepared: 21/01/2013 Date approved: 21/01/2013 Prepared by: TB Approved by: MS Fonts: Helvetica Font size: 7pt Warnings Excipients Braille
PROPOSED
MOCK UP
Felodipine
Parmid XL 5 mg and 10 mg Prolonged Release Tablets
SZ00000LT000
Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet.
What is in this leaflet: 1. What Parmid XL is and what it is used for 2. What you need to know before you take Parmid XL 3. How to take Parmid XL 4. Possible side effects 5. How to store Parmid XL 6. Content of the pack and other information
Parmid XL belongs to a group of medicines called calcium antagonists. These medicines alleviate high blood pressure by dilating the small blood vessels (the arteries) and facilitate the hearts pumping work.
Parmid XL is used in the treatment of high blood pressure.
1 2
What Parmid XL is and what it is used for
Take special care with Parmid XL Talk to your doctor before taking Parmid XL, if you have any or have had any medical condition especially the following: conduction disturbances in the heart heart failure which is in a stable condition increased heart beat rate if the heart valves of your left heart chamber are constricted mild to moderate reduced liver function severe renal failure atrioventricular conduction disturbances of 2nd or 3rd degree. If treatment with Parmid XL is discontinued abruptly, a hypertensive crisis may occur in individual cases.
Do not take Parmid XL if you are allergic to felodipine, or any of the other ingredients of this medicine (listed in section 6) or similar calcium channel blockers (the so-called dihydropyridine derivates). if you are suffering from insufficient blood supply to your tissues with symptoms like e.g. low blood pressure, low pulse, fast heartbeat (shock, including cardiogenic shock). Cardiogenic shock means shock due to severe heart troubles. if you have severe narrowing (stenosis) of the aorta or of the heart valves (mitral or aortic valve). if you suffer from an enlarged heart muscle (hypertrophic cardiomyopathy). if you have had a heart attack, i.e. a blood clot in the heart, within the last 2 months. if you get heart-associated chest pain also at rest or with minimal effort (unstable angina pectoris). if you suffer from a heart failure which was not stabilised by medical measures (decompensated heart failure). if you have any other severe heart disease (e.g. severe heart failure, heart muscle disease or severe valvular disorder). if you have a severe liver disease. if you are pregnant.
What you need to know before you take Parmid XL
Medicines that can reduce the amount of felodipine in the blood: Phenytoin or carbamazepine (medicines for epilepsy) Barbiturates (tranquillising agents and medicines used in the treatment of epilepsy) Rifampicin (antibiotic) Natural remedies containing extract of St. Johns wort (Hypericum perforatum).
Medicines that can increase the amount of felodipine in the blood: Cimetidine (a medicine for stomach ulcers) Certain antibiotics such as erythromycin or telithromycin (antibiotics) Ketoconazole or itraconazole (fungicidal agents) HIV protease inhibitors (antiviral medicines to treat HIV infections, e.g. ritonavir).
Certain other medicines can affect or be affected by Parmid XL. Some of these medicines are: Cyclosporin, tacrolimus (medicines used after organ transplants) Digoxin (medicinal products to strengthen cardiac power).
Medicines that can increase the effect of felodipine: Other medicines used in the treatment of high blood pressure, e.g. beta-blockers, ACE-inhibitors and diuretics Medicine to treat depressions (tricyclic antidepressants) Hydrochlorothiazide (diuretic agent). Parmid XL can enhance low potassium levels in the blood when taken together with water tablets (diuretics).
Parmid XL with food and drink Simultaneous intake of grapefruit or grapefruit juice has influence on the effect of Parmid XL. Pregnancy and breast-feeding Do not take Parmid XL if you are pregnant. Pregnancy must be excluded before starting treatment with Parmid XL. The use of Parmid XL is not recommended in women who are breast-feeding.
The concomitant intake of grapefruit juice should be avoided.
If you are unsure if any of the above apply to you, please discuss this with your doctor. Other medicines and Parmid XL Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
As with other vasodilators, Parmid XL may, in rare cases, precipitate significant low blood pressure with fast heart beat (tachycardia) which in susceptible individuals may result in insufficient blood supply of the heart (myocardial ischaemia). This may lead to a heart attack.
Parmid XL contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Driving and using machines Because of individual variability, the ability to react can be so altered that the ability to drive or operate machinery or work in an unsupported position can be impaired. This applies especially at the start of treatment, when the dosage is increased, when the preparation is changed and in conjunction with alcohol.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Always take this medicine for as long and exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Continued on the next page >>
3
How to take Parmid XL
Artwork Proof Box
A healthy decision Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom. T: 01276 698020 F: 01276 698324 W: www.uk.sandoz.com E: sandoz.artwork@me.com
Ref: V048 product harmonisation + V050 (Nat. phase) Proof no. 005.1 RA Approved? Yes Colours: Black Black 20% Dimensions: 148 x 270 mm Artwork/RA Checklist: Product name Strength/dosage Pack size PL number Storage Date prepared: 21/01/2013 Date approved: 21/01/2013 Prepared by: TB Approved by: MS Fonts: Helvetica Font size: 7pt Warnings Excipients Braille
PROPOSED
MOCK UP
Parmid XL should be taken once daily. Take the tablets whole and not chewed or crushed with a glass of water. The tablets may be taken on empty stomach or with a light meal, however a high-fat meal should be avoided. The recommended dose is: If you are taking Parmid XL for high blood pressure, the recommended starting dose is 5 mg once daily. If necessary, your doctor may increase the dose to 10 mg once daily. The maximum daily dose is 10 mg Parmid XL. Children and adolescents, under 18 years The use of Parmid XL is not recommended in children. The tablets are not intended to be broken.
Elderly patients The recommended initial dose should be adapted in the elderly. Impaired liver or kidney function The dose should be adjusted according to the doctors prescription.
The person concerned should lie down with his/her arms and legs up (resting on a couple of cushions, for example). Symptoms of an overdose are: extreme dizziness and/or feeling very light-headed, caused by very low blood pressure, problems with breathing, having to urinate very often. If you forget to take Parmid XL Take the missed dose as soon as you remember but never take two doses in one day.
If you take more Parmid XL than you should Contact your doctor or the nearest hospital casualty department immediately. Take this leaflet or some tablets with you so that people will know what you have taken.
Very rare (affects less than 1 out of 10,000 people) Disturbances of liver function (elevated transaminase values) Fever Photosensitivity Inflammation in the blood vessels caused by the white blood cells (Leucocytoclastic vasculitis) Enlarged breasts in men Heart attack Abnormally heavy menstruation Inflammation and swelling of the gums, which can be avoided or reduced by good oral hygiene Increased need to urinate. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Rare (affects less than 1 out of 1,000 people) Nettle rash Fainting Vomiting Muscle pain, joint pain Erection disorders.
Uncontrolled shaking Gastro-intestinal complaints (e.g. nausea, vomiting, diarrhoea, constipation) Weight gain Sweating Prickling and tingling sensation of the skin.
Keep out of the sight and reach of children.
5
How to store Parmid XL
If you stop taking Parmid XL Your doctor has told you how long you should take Parmid XL. If you stop the treatment suddenly, your symptoms may come back. Do not stop the treatment earlier than agreed without discussing this with your doctor. Parmid XL is usually used for long-term treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Do not use Parmid XL after the expiry date EXP which is stated on the packaging. The expiry date refers to the last day of that month. Do not store above 25 C. Shelf life in blisters: 4 years.
Contact an emergency room or a doctor immediately if the following side effects occur: Allergic reaction with swelling of the skin of face or extremities, swelling of lips or tongue, swelling of the mucous membranes in the mouth and throat, resulting in shortness of breath and difficulty to swallow (angioedema). Contact an emergency room or a doctor immediately if this occurs. In isolated cases severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis) have been observed. Other possible side effects:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
4
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Possible side effects
What Parmid XL looks like and contents of the pack: Parmid XL 5 mg Tablets are round, pale red to grey-red, biconvex film-coated tablet with embossment F5. Parmid XL 10 mg Tablets are round, pale red to grey-red, biconvex film-coated tablet with embossment F10. Your tablets come in original packs of 10, 20, 28, 30, 50, 56, 100 or 100 x 1 prolonged release tablets. Marketing Authorisation Holder: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. Not all pack sizes may be marketed.
What Parmid XL contains The active substance is felodipine. One prolonged release tablet contains 5 mg or 10 mg of felodipine. The other ingredients are: lactose monohydrate, microcrystalline cellulose, hydroxypropylmethylcellulose, magnesium stearate, sodium lauryl sulphate, macrogol 4000, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).
6
Contents of the pack and other information
Very common (affects more than 1 out of 10 people) Tinnitus (ringing or buzzing in the ears) can occur, especially at the beginning of treatment, when the dose is increased or if high doses are administered. In general these reactions disappear as the treatment continues Peripheral oedema (the degree of ankle swelling is depends on the dose) Particularly at the beginning of treatment, angina pectoris attacks may occur. In patients with pre-existing angina pectoris there may be an increase in the frequency, duration and severity of the attacks. Common (affects less than 1 out of 10 people) Flushing, headache (especially at the beginning of treatment, when the dose is increased or when high doses are administered). In general these reactions disappear as the treatment continues. Uncommon (affects less than 1 out of 100 people) Dizziness Fatigue Low blood pressure A quicker or irregular heart beat Increased heart rate and breathing difficulties Restlessness Pins and needles
Manufacter: Salutas Pharma GmbH, Otto-von-Guericke-Allee 139179, Barleben, Germany Salutas Pharma GmbH, Dieselstrasse 5D-70839, Gerlingen, Germany. or
This leaflet was last revised in 01/2013.
SZ00000LT000
Artwork Proof Box
A healthy decision Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom. T: 01276 698020 F: 01276 698324 W: www.uk.sandoz.com E: sandoz.artwork@me.com
Ref: V048 product harmonisation + V050 (Nat. phase) Proof no. 005.1 RA Approved? Yes Colours: Black Black 20% Dimensions: 148 x 270 mm Artwork/RA Checklist: Product name Strength/dosage Pack size PL number Storage Date prepared: 21/01/2013 Date approved: 21/01/2013 Prepared by: TB Approved by: MS Fonts: Helvetica Font size: 7pt Warnings Excipients Braille
PROPOSED
MOCK UP
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.
