CLARITROMICINA 250 mg Film-Coated Tablets

Зміст інструкції

1. Claritromicina Accord 250 mg film-coated tablets, 500 mg film-coated tablets
   1. What is Claritromicina Accord film-coated tablets and what are they used for
   2. What you need to know before taking Claritromicina Accord film-coated tablets
   3. How to take Claritromicina Accord film-coated tablets
   4. Possible side effects
   5. How to store Claritromicina Accord film-coated tablets
   6. Further information

Claritromicina Accord 250 mg film-coated tablets, 500 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains important
information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Claritromicina Accord film-coated tablets is and what it is used for
• 2. What you need to know before you take Claritromicina Accord film-coated tablets
• 3. How to take Claritromicina Accord film-coated tablets
• 4. Possible side effects
• 5. How to store Claritromicina Accord film-coated tablets
• 6. Contents of the pack and other information

1. What is Claritromicina Accord film-coated tablets and what are they used for

Claritromicina Accord film-coated tablets contain the active ingredient clarithromycin, which belongs
to a group of medicines called macrolide antibiotics.
Antibiotics inhibit the growth of certain bacteria that cause infections.
Claritromicina Accord film-coated tablets are used to treat bacterial infections,
previously diagnosed appropriately by the attending physician, such as:

• lung infections such as bronchitis and community-acquired pneumonia
• throat infections and sinusitis
• skin and tissue infections (e.g. impetigo, erysipelas, erythrasma)
• in combination with appropriate healing of ulcers from Helicobacter pyloriinfection associated with duodenal ulcer (limited to adults only).

Claritromicina Accord film-coated tablets are indicated in adults and adolescents 12 years of age and older.

2. What you need to know before taking Claritromicina Accord film-coated tablets

Do not take Claritromicina Accord film-coated tablets if:

• You are allergic to clarithromycin, other macrolide antibiotics such as erythromycin or azithromycin, or to any of the other ingredients of this medicine (listed in section 6).
• You are taking:
• ergotamine-like medicines (medicines used to treat acute migraine attacks)
• astemizole or terfenadine (medicines to treat hay fever or allergies)
• cisapride (medicine to treat digestive disorders)
• pimozide (medicine to treat psychoses)
• colchicine (medicine to treat gout)
• lovastatin, simvastatin or atorvastatin (medicines to reduce cholesterol levels - a certain type of fat in the blood)
• other medicines known to cause serious heart rhythm disorders
• You are taking a medicine containing lomitapide
• you have abnormally low levels of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia)
• you suffer from severe liver disease in association with kidney disease
• you have an irregular heartbeat.

Warnings and precautions
Talk to your doctor or pharmacist before taking Claritromicina Accord film-coated tablets if:

• you are allergic to the antibiotics lincomycin or clindamycin
• you have kidney and/or liver problems
• you have heart problems, especially 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 breastfeeding
• you develop severe diarrhoea during treatment with clarithromycin tablets or even several weeks after stopping treatment.

Children under 12 years of age
Claritromicina Accord film-coated tablets is not suitable for use in children under 12 years of
age.

Other medicines and Claritromicina Accord film-coated tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Do not take Claritromicina Accord film-coated tablets if you are taking:

• ergotamine, dihydroergotamine (medicines for treating migraine)
• terfenadine or astemizole (medicines for treating hay fever or allergies)
• cisapride (medicine for treating digestive disorders)
• pimozide (medicine for treating psychoses)
• colchicine (medicine for treating gout)
• simvastatin or lovastatin (medicines for lowering cholesterol)
• ticagrelor, ivabradine or ranolazine (medicines for treating heart problems)
• you are taking a medicine containing lomitapide

Caution is required if you are taking:

• digoxin, disopyramide or quinidine (medicines for treating various heart disorders)
• cilostazol (medicine for treating blood circulation problems)
• methylprednisolone (a corticosteroid)
• oral anticoagulants (e.g. warfarin, dabigatran, rivaroxaban, apixaban, edoxaban used to thin the blood)
• nateglinide, pioglitazone, repaglinide, rosiglitazone or insulin (medicines for lowering blood glucose levels)
• sildenafil, vardenafil and tadalafil (medicines for treating impotence in adult males or high blood pressure in the pulmonary vessels)
• vinblastine (medicine for treating cancer)
• valproate, carbamazepine, phenobarbital or phenytoin (medicines for treating epilepsy)
• theophylline (medicine for treating breathing problems)
• omeprazole (medicine for treating indigestion and stomach ulcers) unless your doctor has prescribed it to treat an infection with Helicobacter pylori associated with a duodenal ulcer
• cyclosporine, sirolimus or tacrolimus (used to prevent organ rejection after transplantation)
• etravirine, efavirenz, nevirapine, atazanavir, saquinavir, zidovudine or ritonavir (medicines used to treat human immunodeficiency virus [HIV] infection)
• rifampicin, rifapentine, fluconazole, itraconazole or rifabutin (medicines used to treat certain infections)
• tolterodine (medicine for the treatment of overactive bladder)
• verapamil (medicine for the treatment of high blood pressure)
• St John's Wort (herbal product for the treatment of depression)
• benzodiazepines such as midazolam, triazolam and alprazolam used as sedatives.
• hydroxychloroquine or chloroquine (used for the treatment of conditions that also include rheumatoid arthritis or the treatment or prevention of malaria). Taking these medicines together with clarithromycin may increase the possibility of abnormal heart rhythms and other undesirable effects affecting the heart
• corticosteroids, administered orally, by injection or inhalation (used to help suppress the body’s immune system - this is useful in the treatment of a wide range of conditions)

Clarithromycin does not interact with oral contraceptives.

Claritromicina Accord film-coated tablets with food and drink
Claritromicina Accord film-coated tablets can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding
do not take Claritromicina Accord film-coated tablets without first consulting your doctor.

Driving and using machines
Claritromicina Accord film-coated tablets may make you feel sleepy, dizzy or
confused. If these effects affect you, do not drive vehicles or use machines.

Claritromicina tablets contains sodium
This medicine contains less than 1 mmol of sodium (23mg) per tablet, i.e. essentially ‘sodium
free’.

3. How to take Claritromicina Accord film-coated tablets

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
The recommended dose is:

Adults and adolescents (12 years or older)

• for lung infections, throat infections or sinusitis, skin and soft tissue infections:250 mg twice a day. The doctor may increase the dose to 500 mg twice a day in case of severe infections. The usual duration of treatment is 6-14 days.
• For the treatment ofHelicobacter piloriinfection associated with duodenal ulcers:Claritromicina Accord film-coated tablets can be taken at a dose of 500 mg twice a day in association with other drugs for the treatment of Helicobacter pilori. Your doctor will decide the best combination of treatment suitable for you. If you are not sure which medicine to take and when to take it, talk to your doctor.

Use in children and adolescents
Claritromicina Accord film-coated tablets are not recommended for use in children under 12
years of age. Other pharmaceutical forms are available for these patients, e.g. suspensions.

Hepatic impairment and renal damage
If you have severe liver or kidney problems, your doctor may need to reduce your dose. If you have these
problems, Claritromicina Accord film-coated tablets should not be taken for more than 14 days.

Method of administration
Claritromicina Accord film-coated tablets should be swallowed preferably with a glass of
water.

If you take more Claritromicina Accord film-coated tablets than you should
If you accidentally ingest more tablets in a day than prescribed by your doctor, or if you believe
a child has accidentally ingested some tablets, contact immediately the nearest hospital emergency room or your doctor. An overdose is likely to cause
vomiting and stomach pain.
Bring with you to the hospital or to your doctor this leaflet, all the remaining tablets and the
medicine container, so that they can understand which and how many tablets have been consumed.

If you forget to take Claritromicina Accord film-coated tablets
If you forget to take a tablet, you can take it as soon as you remember, unless
the next dose is scheduled shortly. Do not take more tablets than those prescribed
by your doctor. Donot take a double dose to make up for the missed dose.

If you stop the treatment with Claritromicina Accord film-coated tablets
Do not stop the treatment with the medicine because you feel better. It is important that you complete the
treatment cycle prescribed by your doctor otherwise the symptoms may return and the medicine may be less
effective the next time.
If you have any doubts about 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.
If you experience any of the following conditions at any time during treatment,
STOP TAKING the tablets and immediately inform your doctor:

• Severe and prolonged diarrhoea, with the presence of blood or mucus. Diarrhoea may occur more than two months after treatment with clarithromycin, in which case you should still inform your doctor.
• Skin 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, abdominal pain or loss of appetite. These may be symptoms that the liver may not be functioning properly.
• Severe skin reactions such as blisters on the skin, mouth, lips, eyes and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis).
• Fast or irregular heartbeat.
• Severe pain in the abdomen and back caused by inflammation of the pancreas.

Common side effects (may affect up to 1 in 10 people):

• headache
• sleep disturbances
• changes in taste
• stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea
• abnormal liver function (resulting from blood tests)
• skin rash
• increased sweating

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

• oral or vaginal thrush (a fungal infection)
• reduction in the level of certain blood cells (which may lead to a greater likelihood of infections or increase the risk of bruising or bleeding)
• loss of appetite, heartburn, bloating, constipation, gas
• anxiety, nervousness, drowsiness, fatigue, dizziness, tremor or agitation, or a general feeling of being unwell
• ringing in the ears or hearing loss
• dizziness
• inflammation of the mouth or tongue
• dry mouth
• joint pain
• chest pain or changes in heart rhythm such as palpitations
• a change in liver levels, inflammation of the liver, an inability of the liver to function properly or liver failure (you may notice yellowing of the skin, dark urine, pale stools or itchy skin)
• abnormal blood test results

Not known (frequency cannot be estimated from available data)

• swelling, redness and itching of the skin. Sometimes scales, brown spots and small palpable bleeding under the skin may appear, often accompanied by joint and abdominal pain (Schönlein-Henoch purpura), contact your doctor immediately if a severe skin reaction occurs: a red and scaly rash with bumps under the skin and blisters (pustular exanthematous rash)
• acne
• inflammation of the pancreas
• confusion, hearing loss, hallucinations (seeing things), change in sense of reality and feeling of panic, depression, abnormal dreams or nightmares
• convulsions (fits)
• bleeding
• discoloration 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 muscles become easily weak and tired) clarithromycin may worsen these symptoms
• low blood sugar levels
• inflammation of the kidneys or inability of the kidneys to function properly (you may notice fatigue, swelling or oedema of the face, abdomen, thighs or ankles or problems with urination) or kidney failure

Reporting of suspected adverse reactions
If you get any side effects, even those not listed in this leaflet, please tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Claritromicina Accord film-coated tablets

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 outer packaging and on the blister after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular temperature storage conditions.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Further information

What Claritromicina Accord contains

• Each Claritromicina Accord tablet contains 250 or 500 mg of the active ingredient clarithromycin.
• The other ingredients are: Tablet core: microcrystalline cellulose (E460), sodium croscarmellose, povidone K30, talc (E553b), anhydrous colloidal silica, magnesium stearate (E470b), stearic acid 50. Coating: Opadry Yellow containing hypromellose 2910 (5mPa.s) (E464), propylene glycol (E1520), titanium dioxide (E171), vanillin, hydroxypropylcellulose (E463), talc (E553b), quinoline yellow (E104).

Description of the appearance of Claritromicina Accord and contents of the pack
Claritromicina Accord 250 mg film-coated tablets are film-coated tablets of light yellow color, oval biconvex shape, with “C1” imprinted on one side.
The length of the 250 mg tablet is approximately 14.90 mm and the thickness is approximately 7.10 mm.
Claritromicina Accord 500 mg film-coated tablets are film-coated tablets of light yellow color, oval biconvex shape, with “C” and “2” imprinted on each side of the score line. The tablet
can be divided into equal doses. The length of the 500 mg tablet is approximately 18.60 mm and the thickness is
approximately 8.85 mm.
Claritromicina Accord 250 mg film-coated tablets are available in blisters of 10, 12, 14, 16, 20, 21,
30, 250 and 500 tablets while Claritromicina Accord 500 mg film-coated tablets are available in
blisters of 7, 10, 14, 16, 20, 21, 28, 30, 250 and 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona,
s/n, Edifici Est 6ª planta
08039-Barcelona,
Spain.

Manufacturer
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
Netherlands
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040, Barcelona,
Spain
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare Single Member S.A.
64th Km National Road Athens,
Lamia, 32009, Greece

This medicinal product is authorised in the Member States of the European Economic Area under the following
names: