CLARITHROMYCIN ACCORD 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Claritromicina Accord 500 mg Film-Coated Tablets EFG

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.

Contents of the Package Leaflet

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

1. What is Claritromicina Accord and what is it used for

Claritromicina Accord contains the active substance clarithromycin, which belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of certain bacteria that cause infections. Claritromicina Accord is used to treat bacterial infections, which must first be diagnosed by your doctor, such as:

• Chest infections, such as bronchitis and community-acquired pneumonia
• Throat and sinus infections
• Skin and soft tissue infections (e.g. impetigo, erysipelas, erythrasma)
• In combination with an infection of Helicobacter pylorifor the treatment of duodenal ulcer (restricted to adults only).

Claritromicina Accord is indicated in adults and adolescents 12 years of age and older.

2. What you need to know before you take Claritromicina Accord

Do not take Claritromicina Accord:

• ergotamine-type medicines (for the treatment of migraine)
• astemizole or terfenadine (for the treatment of hay fever or allergy)
• cisapride (for the treatment of digestive problems)
• pimozide (for the treatment of psychiatric disorders)
• colchicine (for the treatment of gout)
• lovastatin, simvastatin, or atorvastatin (medicines used to lower cholesterol)
• if you are taking a medicine containing lomitapide.
• if you are taking other medicines known to cause serious heart rhythm disturbances
• if you have low levels of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia)

Warnings and precautions

Consult your doctor or pharmacist before taking Claritromicina Accord:

Children under 12 years

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

Other medicines and Claritromicina Accord

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Claritromicina Accord if you are taking:

• ergotamine, dihydroergotamine (for the treatment of migraine)
• terfenadine or astemizole (for the treatment of hay fever or allergy)
• cisapride (for the treatment of digestive problems)
• pimozide (for the treatment of psychiatric disorders)
• colchicine (for the treatment of gout)
• simvastatin or lovastatin (medicines used to lower cholesterol)
• ticagrelor, ivabradine, or ranolazine (medicines for the treatment of heart problems)
• if you are taking a medicine containing lomitapide

You should pay special attention if you are taking:

• digoxin, disopyramide, quinidine (medicines for the treatment of various heart conditions)
• cilostazol (medicines for the treatment of poor circulation)
• methylprednisolone (a corticosteroid)
• oral anticoagulants (e.g. warfarin, dabigatran, rivaroxaban, apixaban, edoxaban)
• nateglinide, pioglitazone, repaglinide, rosiglitazone, or insulin (medicines to lower blood sugar levels)
• sildenafil, vardenafil, and tadalafil (medicines for the treatment of erectile dysfunction or to treat pulmonary hypertension)
• vinblastine (a medicine for the treatment of cancer)
• valproate, carbamazepine, phenobarbital, or phenytoin (medicines for the treatment of epilepsy)
• theophylline (a medicine for the treatment of respiratory problems)
• omeprazole (a medicine for the treatment of indigestion and stomach ulcers) except if your doctor has prescribed it for the treatment of Helicobacter pyloriinfection associated with duodenal ulcer
• ciclosporin, sirolimus, or tacrolimus (to prevent organ rejection after a transplant)
• etravirine, efavirenz, nevirapine, atazanavir, saquinavir, zidovudine, or ritonavir (medicines used for the treatment of HIV infection)
• rifampicin, rifapentine, fluconazole, itraconazole, or rifabutin (medicines used for the treatment of certain infections)
• tolterodine (a medicine for the treatment of an overactive bladder)
• verapamil (a medicine for the treatment of high blood pressure)
• St. John's Wort (a herbal medicine used for the treatment of depression)
• benzodiazepine medicines such as midazolam, triazolam, and alprazolam used as sedatives
• hydroxychloroquine or chloroquine (used to treat diseases such as rheumatoid arthritis, or to treat or prevent malaria). Taking these medicines at the same time as clarithromycin may increase the chance of abnormal heart rhythms and other serious side effects affecting the heart.
• corticosteroids, given orally, by injection, or inhaled (used to suppress the immune system; this is useful in the treatment of a wide range of diseases)

Clarithromycin does not interact with oral contraceptives.

Taking Claritromicina Accord with food and drink

Claritromicina Accord can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

Claritromicina Accord may make you feel drowsy, dizzy, or confused. Do not drive or operate machinery if you are affected.

Claritromicina Accord contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free"

3. How to take Claritromicina Accord

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

The recommended doses are:

Adults and adolescents (12 years of age and older):

• For chest infections, throat or sinus infections, and skin and soft tissue infections:250 mg twice a day. Your doctor may increase the dose to 500 mg twice a day in severe infections. The usual duration of treatment is 6 to 14 days.

• For the treatment of Helicobacter pyloriinfections associated with duodenal ulcers:

500 mg twice a day in combination with other medicines for the treatment of Helicobacter pylori.

Your doctor will decide the best combination of treatment for you. If you are not sure what medicine to take or when to take it, talk to your doctor.

Use in children and adolescents

Claritromicina Accord is not recommended for use in children under 12 years of age. For these patients, other pharmaceutical forms are available, such as suspensions.

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

Claritromicina Accord should be swallowed preferably with a glass of water.

If you take more Claritromicina Accord than you should

If you accidentally take more tablets in one day than your doctor has told you, or if a child accidentally swallows some tablets, contact your doctor or the nearest hospital emergency department immediately. An overdose is likely to cause vomiting and stomach pain. Please take this leaflet, the remaining tablets, and the packaging to the hospital or doctor so they know what tablets were taken.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Claritromicina Accord

If you forget to take a dose of Claritromicina Accord, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and continue with the rest as before. Do not take a double dose to make up for missed doses.

If you stop taking Claritromicina Accord

Do not stop taking your medicine because you feel better. It is important to take the tablets for the duration your doctor has prescribed, otherwise the problem may come back and this medicine may be less effective next time.

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.

STOP taking Claritromicina Accord and contact your doctor immediately if you experience any of the following symptoms during treatment:

• severe or prolonged diarrhoea, which may have blood or mucus. Diarrhoea may occur during or up to two months after treatment with clarithromycin, in which case you should contact 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 tenderness, or loss of appetite. These may be signs that your liver is not working 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)
• rapid or irregular heartbeats
• severe abdominal and back pain caused by pancreatitis

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

• headache
• difficulty sleeping
• changes in taste
• stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea
• abnormal liver function (seen in blood tests)
• skin rash
• excessive sweating

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

• oral or vaginal candidiasis (a fungal infection)
• decrease in the number of certain types of blood cells, making you more likely to get infections or increasing the risk of bruising or bleeding
• loss of appetite, acid reflux, bloating, constipation, wind
• anxiety, nervousness, drowsiness, fatigue, dizziness, tremors, or chills or a general feeling of being unwell
• hearing loss or ringing in the ears (tinnitus)
• vertigo
• inflammation of the stomach, mouth, and tongue
• dry mouth
• joint pain
• chest pain or changes in heart rhythm such as palpitations
• a change in the levels of substances produced by the liver, liver inflammation, liver failure, or liver dysfunction (you may notice yellowing of the skin, dark urine, pale stools, or itching of the skin)
• abnormal blood test results

Side effects of unknown frequency(cannot be estimated from the available data):

• swelling, redness, or itching of the skin. Sometimes, small brown scales may appear, often with joint and abdominal pain (Henoch-Schönlein purpura), contact a doctor immediately if you experience a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (pustular exanthem)
• acne
• pancreatitis
• confusion, loss of balance, hallucinations (seeing things), change in sense of reality, or panic, depression, abnormal dreams, or nightmares
• seizures (convulsions)
• 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 have myasthenia gravis (a condition in which the muscles become weak and tire easily), clarithromycin may worsen these symptoms
• low blood sugar levels
• kidney inflammation or kidney failure (you may notice tiredness, swelling, or puffiness in the face, abdomen, thighs, or ankles, or problems with urination) or kidney dysfunction

Reporting of side effects:

If you experience 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 Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Claritromicina Accord

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

This medicine does not require any special storage conditions. Keep in the original packaging to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton or blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Content and Additional Information

Composition of Clarithromycin Accord

• The active ingredient is clarithromycin. Each tablet contains 500 mg of clarithromycin.
• The other excipients are:

Tablet Core:Microcrystalline cellulose (E460), Sodium croscarmellose, Povidone K30, Talc (E553b), Colloidal anhydrous silica, Magnesium stearate (E470b), Stearic acid 50.

Coating:Yellow Opadry contains: Hypromellose 2910 (5mPa.s) (E464), Propylene glycol (E1520), Titanium dioxide (E171), Vanillin, Hydroxypropylcellulose (E463), Talc (E553b), Quinoline yellow (E104)

Product Appearance and Container Content

Clarithromycin Accord 500 mg film-coated tablets EFG: light yellow, oval, biconvex tablets marked with a "C" on one side and "2" on the other side of the tablet. The tablets have a length of 18.60 mm and a width of 8.85 mm.

Clarithromycin Accord 500 mg film-coated tablets EFG are packaged in blisters of 7, 10, 14, 16, 20, 21, 28, 30, 250 or 500 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Accord Healthcare S.L.U.

World Trade Center

Moll de Barcelona, s/n

Edifici Est, 6th floor

08039 Barcelona

Manufacturer

Accord Healthcare B.V.,

Winthontlaan 200,

3526 KV Utrecht,

Netherlands

Laboratori Fundació Dau

C/ C, 12-14 Pol. Ind. Zona Franca,

Barcelona, 08040,

Spain

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50,95

95-200 Pabianice,

Poland

Accord Healthcare Single Member S.A.

64th Km National Road Athens,

Lamia, 32009,

Greece

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

Germany Clarithromycin Accord 500 mg Filmtabletten

Austria Clarithromycin Accord 500 mg Filmtabletten

Denmark Clarithromycin Accord

Spain Clarithromycin Accord 500 mg film-coated tablets

Finland Clarithromycin Accord 500 mg tablets, film-coated

France Clarithromycin Accord 500 mg film-coated tablets

Ireland Clarithromycin 500 mg film-coated tablets

Italy Clarithromycin Accord

Norway Clarithromycin Accord

Netherlands Clarithromycin Accord 500 mg film-coated tablets

Poland Klabiotic

Date of the last revision of this leaflet:March 2024

Detailed information on this medicinal product is available on the website of the {Spanish Agency for Medicines and Health Products (AEMPS)} (http://www.aemps.gob.es/)