KLARICID ADULT SACHET 250MG

Active substance: CLARITHROMYCIN

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PATIENT INFORMATION LEAFLET ON

Klaricid Adult Sachets 250mg/sachet
(Clarithromycin)

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor
or your 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 of the side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in the leaflet.
See section 4.
What is in this leaflet:
1. What Klaricid Adult Sachets are and what they are used for
2. What you need to know before taking Klaricid Adult Sachets
3. How to take Klaricid Adult Sachets
4. Possible side effects
5. How to store Klaricid Adult Sachets
6. Contents of the pack and other information
1. What Klaricid Adult Sachets are and what they are used for
Each Klaricid Adult sachet contains 250 mg of the active ingredient clarithromycin. Klaricid belongs
to a group of medicines called macrolide antibiotics.
Antibiotics stop the growth of bacteria (bugs) that cause infections. Klaricid Adult Sachets are used
to treat infections such as:
1. Chest infections such as bronchitis and pneumonia
2. Throat and sinus infections
3. Skin and tissue infections
4. Helicobacter pylori infection associated with duodenal ulcer.
Klaricid Adult Sachets are indicated in adults and children 12 years and older.
2. What you need to know before taking Klaricid Adult Sachets
Do not take Klaricid Adult Sachets if you;
• know that you are allergic to clarithromycin, other macrolide antibiotics such as
erythromycin or azithromycin, or any of the other ingredients in the sachets.
• are taking medicines called ergotamine or dihydroergotamine tablets or use
ergotamine inhalers for migraine.
• are taking medicines called terfenadine or astemizole (widely taken for hay fever or
allergies) or cisapride (for stomach problems) or pimozide (for mental health problems) as combining
these drugs can sometimes cause serious disturbances in heart rhythm.
• are taking lovastatin or simvastatin (HMG-CoA reductase inhibitors, commonly known as statins,
used to lower levels of cholesterol (a type of fat) in the blood).
• have low levels of potassium in the blood (a condition known as hypokalaemia).
• have severe liver disease with kidney disease.
• have an irregular heart rhythm.
• are taking medicines called ticagrelor or ranolazine (for heart attack, chest pain or angina)
• are taking colchicine (usually taken for gout)
Warnings and precautions
Talk to your doctor or pharmacist before taking Klaricid Adult Sachets
• if you have any liver or kidney problems
Clarithromycin
• if you have, or are prone to, fungal infections (e.g. thrush)
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• if you are pregnant or breast feeding
• if you have an intolerance to any sugars as Klaricid Adult Sachets contain sucrose.
Other medicines and Klaricid Adult Sachets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines
as your dose may need to be changed or you may need to have regular tests performed:
• digoxin, quinidine or disopyramide (for heart problems)
• warfarin (for thinning the blood)
• carbamazepine, valproate, phenobarbital or phenytoin (for epilepsy)
• atorvastatin, rosuvastatin (HMG-CoA reductase inhibitors, commonly known as statins, and used
to lower levels of cholesterol (a type of fat) in the blood). Statins can cause rhabdomyolosis (a
condition which causes the breakdown of muscle tissue which can result in kidney damage) and
signs of myopathy (muscle pain or muscle weakness) should be monitored.
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (used to lower blood glucose levels)
• theophylline (used in patients with breathing difficulties such as asthma)
• triazolam, alprazolam or midazolam (sedatives)
• cilostazol (for poor circulation)
• omeprazole (for treatment of indigestion and gastric ulcers) unless your doctor has prescribed it
to treat Helicobacter pylori infection associated with duodenal ulcer
• methylprednisolone (a corticosteroid)
• vinblastine (for treatment of cancer)
• ciclosporin, sirolimus and tacrolimus (immune suppressants)
• etravirine, efavirenz, nevirapine, ritonavir, zidovudine, atazanavir, saquinavir (anti-viral drugs used
in the treatment of HIV)
• rifabutin, rifampicin, rifapentine, fluconazole, itraconazole (used in the treatment of certain
bacterial infections)
• tolterodine (for overactive bladder)
• verapamil, amlodipine, diltiazem (for high blood pressure)
• sildenafil, vardenafil and tadalafil (for impotence in adult males or for use in pulmonary arterial
hypertension (high blood pressure in the blood vessels of the lung))
• St John’s Wort (a herbal product used to treat depression)
• aminoglycosides (a group of antibiotic to treat certain bacteria for example gentamicin, neomycin)
Klaricid does not interact with oral contraceptives.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby,
ask your, doctor or pharmacist before taking Klaricid Adult Sachets as the safety of Klaricid Adult
Sachets in pregnancy and breast-feeding is not known.
Driving and Using Machines:
Klaricid Adult Sachets may make you feel dizzy or drowsy. If they affect you in this way do not drive,
operate machinery or do anything that requires you to be alert.
3. How to take Klaricid Adult Sachets
Do not give these sachets to children under 12 years. Your doctor will prescribe another suitable
medicine for your child.
You may initially be given a pack containing two Klaricid Adult Sachets so that you can start your
treatment straight away. This sachet pack is not a full course of treatment. You should also receive
a prescription for the rest of the sachets that you need.
Mix the contents of the sachet with a small amount of water before taking to make the granules
easier to swallow.
For the treatment of chest infections, throat or sinus infections and skin and soft tissue
infections:
The usual dose of Klaricid Adult Sachets for adults and children over 12 years is 250 mg (1 sachet)
twice a day for 6 to 14 days e.g. one sachet in the morning and one sachet in the early evening. Your
doctor may increase the dose to 500 mg (2 sachets) twice daily in severe infections.
For the treatment of Helicobacter pylori infection associated with duodenal ulcers: There are
a number of effective treatment combinations available to treat Helicobacter pylori in which Klaricid
Adult Sachets are taken together with one or two other drugs. These combinations include the
following and are usually taken for 6 to 14 days:
a) Two Klaricid Adult Sachets taken twice a day together with amoxycillin, 1000mg taken twice a
day plus lansoprazole, 30mg twice a day.
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b) Two Klaricid Adult Sachets taken twice a day together with metronidazole 400mg taken twice a
day plus lansoprazole, 30mg twice a day.
c) Two Klaricid Adult Sachets taken twice a day together with amoxycillin, 1000mg taken twice a
day or metronidazole 400mg taken twice a day plus omeprazole, 40mg a day.
d) Two Klaricid Adult Sachets taken twice a day together with amoxycillin, 1000mg taken twice a
day plus omeprazole, 20mg taken once a day.
e) Two Klaricid Adult Sachets taken three times a day together with omeprazole 40mg taken once a
day.
The treatment combination that you receive may differ slightly from the above. Your doctor will
decide which treatment combination is the most suitable for you. If you are unsure which medicine
you should be taking or how long you should be taking it for, please consult your doctor for advice.
If you take more Klaricid Adult Sachets than you should
If you accidentally take more Klaricid Adult Sachets in one day than your doctor has told you to,
or if a child accidentally swallows the contents of a sachet, contact your doctor or nearest hospital
emergency department immediately. An overdose of Klaricid Adult Sachets is likely to cause
vomiting and stomach pains.
If you forget to take Klaricid Adult Sachets
If you forget to take a Klaricid Adult Sachet, take one as soon as you remember. Do not
take more sachets in one day than your doctor has told you to.
If you stop taking Klaricid Adult Sachets
Do not stop taking Klaricid Adult Sachets, even if you feel better. It is important to take the sachets
for as long as the doctor has told you to, otherwise the problem might come back.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Klaricid Adult Sachets can cause side effects although not
everybody gets them.
If you suffer from any of the following at any time during your treatment STOP TAKING
your sachets and contact your doctor immediately:
• severe or prolonged diarrhoea, which may have blood or mucus in it. Diarrhoea
may occur over two months after treatment with clarithromycin, in which case you
should still contact your doctor.
• a rash, difficulty breathing, fainting or swelling of the face and throat. This is a sign that you may
have developed an allergic reaction.
• yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tender abdomen or loss of
appetite. These may be signs that your liver may not be working properly.
• severe skin reactions such as blistering of the skin, mouth, lips, eyes and genitals (symptoms of
a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis).
• muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of
muscle tissue which can result in kidney damage).
Common side effects of Klaricid Adult Sachets include;
• headache
• difficulty sleeping
• changes in sense of taste
• stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea
• a change in the way the liver works
• skin rash
• increased sweating
Other less common side effects include:
• swelling, redness or itchiness of the skin
• acne
• oral or vaginal ‘thrush’ (a fungal infection)
• reduction in the level of certain blood cells (which can make infections more likely or increase the
risk of bruising or bleeding)
• loss of appetite, heartburn, bloating, constipation, wind
• inflammation of the pancreas
Clarithromycin
• anxiety, nervousness, drowsiness, tiredness, dizziness, tremor or shaking
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• confusion, loss of bearings, hallucinations (seeing things), change in sense of reality or panicking,
depression, abnormal dreams or nightmares
• convulsion (fits)
• ringing in the ears or hearing loss
• vertigo
• paraesthesia, more commonly known as ‘pins and needles’
• nose bleeds
• leaking of blood from blood vessels (haemorrhage)
• inflammation of the mouth or tongue
• discolouration of the tongue or teeth
• dry mouth
• loss of taste or smell or inability to smell properly
• joint pain
• muscle pain or loss of muscle tissue. If you suffer from myasthenia gravis (a condition in which
the muscles become weak and tire easily) or rhabdomyolysis (a condition which causes the
breakdown of muscle tissue), clarithromycin may worsen these symptoms
• chest pain or changes in heart rhythm such as palpitations
• a change in the levels of products made by the liver, inflammation of the liver or an inability of the
liver to function properly (you may notice yellowing of the skin, dark urine, pale stools or itchiness
of the skin)
• a change in the levels of products produced by the kidney, inflammation of the kidney or an
inability of the kidney to function properly (you may notice tiredness, swelling or puffiness in the
face, abdomen, thighs or ankles or problems with urination)
• a change in the levels of certain cells or products found in the blood
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
5. How to store Klaricid Adult Sachets
Keep this medicine out of sight and reach of children
Do not use these sachets after their use-by (exp) date that is printed on the box and
indented on the sachet.
Store these sachets below 30 °C in a cool, dry place.
Do not throw away any medicines via wastewater or household water. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Klaricid Adult Sachets contain
Each Klaricid Adult Sachets contains 250 mg of the active ingredient clarithromycin.
Other ingredients are: carbomers (carbopol 974P), hypromellose phthalate, castor oil, silicon dioxide,
maltodextrin, sucrose, titanium dioxide, Ultrasperse modified starch, orange bramble flavour,
ammonium glycyrrhizinate and acesulfame potassium.
What Klaricid Adult Sachets look like and contents of the pack
Klaricid 250 mg sachets are available in packs containing 2* or 14 sachets.
*The 2 sachet pack is a starter pack and is not a full course of treatment.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder: - Abbott Laboratories Ltd., Abbott
House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, SL6 4XE, UK.
Manufacturer: - Abbott S.r.l., Via Pontina Km 52, 04011 Campoverde di Aprilia, Italy.
This leaflet was last revised in May 2014.

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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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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