CLARITHROMYCIN 250 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - CLARITHROMYCIN 250 MG FILM-COATED TABLETS

Package leaflet: Information for the patient

(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 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 signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Clarithromycin is and what it is used for
2. What you need to know before you take Clarithromycin
3. How to take Clarithromycin
4. Possible side effects
5. How to store Clarithromycin
6. Contents of the pack and other information

1. what clarithromycin is and what it is used for

Clarithromycin contains the active substance clarithromycin which belongs to a group of medicines called macrolide antibiotics.

Antibiotics stop the growth of certain bacteria which cause infections.

Clarithromycin is used to treat infections in adults and adolescents 12 years and older, such as:

bronchitis and community acquired pneumonia
Throat and sinus infections
Skin and tissue infections (e.g. impetigo, erysipelas, erythrasma)
in combination with appropriate ulcer healing Helicobacter pylori infection associated with duodenal ulcer (restricted to adults only).

2. what you need to know before you take clarithromycin you are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or any of the other ingredients of this medicine (listed in section 6.)

you are taking

– ergotamine-like medicinal products (medicines for the treatment of acute migraine attacks)

– astemizole or terfenadine (medicines for the treatment of hay fever or allergies)

– cisapride (medicine used for the treatment of digestive problems)

– pimozide (medicine for the treatment of psychoses)

– colchicine (medicine for the treatment of gout)

– lovastatin, simvastatin or atorvastatin (medicines to reduce cholesterol levels (a certain type of fat) in the blood)

– other medicines which are known to cause serious disturbances in heart rhythm

– a medicine containing lomitapide

you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia)

you have severe liver disease in combination with kidney disease

you have an irregular heart rhythm.

Warnings and precautions

Talk to your doctor or pharmacist before taking Clarithromycin if:

you are allergic to the antibiotics lincomycin or clindamycin
you have any liver or kidney problems
you have heart problems, in particular heart rhythm problems (e.g. long QT syndrome)
you have or are prone to fungal infections (e.g., thrush)
you have diabetes
you are pregnant or breast-feeding
you develop severe diarrhea while taking Clarithromycin, or even several weeks after you have stopped taking it

Children under 12 years of age

Clarithromycin is not suitable for use in children under 12 years of age.

Other medicines and Clarithromycin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines: ergotamine, dihydroergotamine (medicines for the treatment of migraine)

terfenadine or astemizole (medicines for the treatment of hay fever or allergies)

cisapride (medicine for the treatment of digestive problems)

pimozide (medicines for the treatment of psychiatric disorders)

colchicine (medicine for the treatment of gout)

simvastatin or lovastatin (medicines used to lower cholesterol)

ticagrelor or ranolazine (medicines for the treatment of heart problem)

digoxin, disopyramide or quinidine (medicines for the treatment of various heart conditions)

cilostazol (medicine for the treatment of poor blood circulation)

methylprednisolone (a corticosteroid)

warfarin or any other anticoagulant e.g. dabigatran, rivaroxaban, apixaban (used to thin your blood)

nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (medicines to lower blood glucose levels)

sildenafil, vardenafil and tadalafil (medicines for the treatment of impotence in adult males or to treat high blood pressure in the blood vessels of the lungs)

vinblastine (medicine for the treatment of cancer)

valproate, carbamazepine, phenobarbital or phenytoin (medicines for the treatment of epilepsy)

theophylline (medicine for the treatment of breathing problems)

omeprazole (medicine for the treatment of indigestion and gastric ulcers) unless your doctor has prescribed it for you to treat Helicobacter pylori infection associated with duodenal ulcer)

ciclosporin, sirolimus or tacrolimus (used to prevent organ rejection after transplant)etravirine, efavirenz, nevirapine, atazanavir, saquinavir, zidovudine or ritonavir (medicines used for the treatment of human immunodeficiency virus [HIV]infection)

rifampicin, rifapentine, fluconazole, itraconazole or rifabutin (medicines used for the treatment of certain infections)
tolterodine (medicine for the treatment of an overactive bladder)
verapamil (medicine for the treatment of high blood pressure)
St John’s wort (a herbal product used to treat depression)
benzodiazepine drugs such as midazolam, triazolam and alprazolam used as sedatives

Clarithromycin does not interact with oral contraceptives.

Clarithromycin with food and drink

Clarithromycin tablets may be taken with or without food.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, do not take Clarithromycin without consulting your doctor first.

Driving and using machines

Clarithromycin may make you feel sleepy, dizzy or confused. DO NOT drive or operate machinery if you are affected.

3. how to take clarithromycin

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults and adolescents (aged 12 years and older)

For chest infections, throat or sinus infections and skin and soft tissue infections

250 mg clarithromycin twice daily. Your doctor may increase the dose to 500 mg clarithromycin twice daily in severe infections. The usual duration of treatment is 6 to 14 days.

For the treatment of Helicobacter pylori infection associated with duodenal ulcers: Clarithromycin should be taken in a dose of 500 mg twice daily in combination with other medicines to treat Helicobacter pylori.

Your doctor will decide on the best treatment combination for you. If you are at all unsure as to which medicine to take and when to take the medicine you must speak to your doctor.

Use in children and adolescents

Clarithromycin is not recommended for use in children under 12 years of age. For these patients other pharmaceutical forms e.g. suspensions are available.

Patients with liver or kidney problems

If you have liver or severe kidney problems your doctor may need to reduce your dose. Clarithromycin should not be taken for more than 14 days if you have these problems

Method of administration

Clarithromycin tablets should be swallowed preferably with a glass of water.

If you take more Clarithromycin than you should

If you accidentally take more Clarithromycin tablets in one day than your doctor has told you to, or if a child accidentally swallows some tablets, contact your doctor or nearest hospital emergency department immediately. An overdose of Clarithromycin tablets is likely to cause vomiting and stomach pains.

Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Clarithromycin

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next dose. DO NOT take more tablets in one day than your doctor has told you to Do not take a double dose to make up for a forgotten dose.

If you stop taking Clarithromycin

DO NOT stop taking Clarithromycin because you are feeling better. It is important to take the tablets for as long as the doctor has told you to, otherwise symptoms may return.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects:

If you suffer from any of the following at any time during your treatment STOP TAKING Clarithromycin and contact your doctor immediately:

a rash, difficulty breathing, fainting or swelling of the face and throat. This is a sign that you may have developed an allergic reaction.
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).
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.
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.
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), or kidney failure
confusion, loss of bearings, hallucinations (seeing things), change in sense of reality or panicking, depression, abnormal dreams or nightmares
Common side effects (may affect up to 1 in 10 people) include; headache

difficulty sleeping changes in sense of taste stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea abnormal liver function (seen in blood results)

skin rash

increased sweating

Uncommon side effects (may affect up to 1 in 100 people) include:

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
anxiety, nervousness, drowsiness, tiredness, dizziness, tremor or shaking, or a general feeling of being unwell
ringing in the ears or hearing loss
vertigo
inflammation of the mouth or tongue
dry mouth
joint pain
chest pain or changes in heart rhythm such as palpitations (fast or irregular heart beat)
a change in the levels of products made by the liver, inflammation of the liver or an inability of the liver to function properly or liver failure (you may notice yellowing of the skin, dark urine, pale stools or itchiness of the skin)
abnormal blood test results.

Side effects for which the frequency is not known (cannot be estimated from the available data) include:

contact a doctor immediately if you experience a serious skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis)
small palpable bleedings in the skin, often with joint and adominal pain
acne
severe pain in the abdomen and back, caused by inflammation of the pancreas.
confusion, loss of bearings, hallucinations (seeing things), change in sense of reality or panicking, depression, abnormal dreams or nightmares
convulsion (fits)
bleeding
discolouration of the tongue or teeth
loss of taste or smell or inability to smell properly
deafness
muscle pain or loss of muscle tissue. If you suffer from myasthenia gravis (a condition in which the muscles become weak and tire easily) clarithromycin may worsen these symptoms
low blood sugar levels
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), or kidney failure

Reporting of 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. You can also report side effects directly via the national reporting system

By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store clarithromycin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater <or household waste>. 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- the active substance is clarithromycin.

Each film-coated tablet contains 250 mg clarithromycin.

– The other ingredients are:

What Clarithromycin film-coated tablets look like and contents of the pack

Clarithromycin 250 mg film-coated tablets: white or almost white capsular shaped film-coated tablets, debossed with “S21” on one side and blank on the other side. The tablet size is 14*6.5mm.

Pack sizes:

6, 10, 12, 14, 15, 16, 20 or 24 tablets in white PVC/PVDC/ALU blister.

Not all pack sizes may be marketed

Marketing Authorisation Holder

HEC Pharm GmbH

Gabriele-Tergit-Promenade 17, 10963 Berlin

Germany

Manufacturer

Formula Pharmazeutische und chemische Entwicklungs GmbH

Goerzallee 305b, D-14167 Berlin