Clarithromycin Accord

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

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

Claritromycin Accord film-coated tablets are indicated in adults and adolescents aged 12 years and older.

2. What you should know before taking Clarithromycin Accord film-coated tablets

Do not take Clarithromycin 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 used to treat hay fever or allergies)
  • cisapride (a medicine used to treat digestive disorders)
  • pimozide (a medicine used to treat psychosis)
  • colchicine (a medicine used to treat gout)
  • lovastatin, simvastatin or atorvastatin (medicines used to reduce cholesterol levels – a type of fat in the blood)
  • other medicines known to cause serious disturbances in heart rhythm
• You are taking a medicine containing lomitapide
  • you have abnormally low levels of potassium or magnesium in your blood (hypokalaemia or hypomagnesaemia)
  • you have severe liver disease associated with kidney disease
  • you have an irregular heartbeat.

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

• you are allergic to lincomycin or clindamycin antibiotics
• you have kidney and/or liver problems
• you have heart problems, especially rhythm disorders (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
Clarithromycin Accord film-coated tablets are not suitable for use in children under 12 years of age.
Other medicines and Clarithromycin 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 Clarithromycin Accord film-coated tablets if you are taking:

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

Caution is required if you are taking:

• digoxin, disopyramide or quinidine (medicines for various heart disorders)
• cilostazol (a medicine for 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 to lower blood glucose levels)
• sildenafil, vardenafil and tadalafil (medicines for erectile dysfunction in adult males or for high blood pressure in the lung vessels)
• vinblastine (a medicine for treating cancer)
• valproate, carbamazepine, phenobarbital or phenytoin (medicines for epilepsy)
• theophylline (a medicine for respiratory problems)
• omeprazole (a medicine for indigestion and stomach ulcers) unless your doctor has prescribed it specifically to treat Helicobacter pylori infection associated with 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 (a medicine for treatment of overactive bladder)
• verapamil (a medicine for treatment of high blood pressure)
• St. John’s wort (an herbal remedy for depression)
• benzodiazepines such as midazolam, triazolam and alprazolam used as sedatives
• hydroxychloroquine or chloroquine (used for treatment of conditions including rheumatoid arthritis or for treatment or prevention of malaria). Taking these medicines together with clarithromycin may increase the risk of abnormal heart rhythms and other heart-related side effects
• corticosteroids administered orally, by injection or by inhalation (used to help suppress the body's immune system – this is useful in treating a wide range of conditions)

Clarithromycin does not interact with oral contraceptives.
Clarithromycin Accord film-coated tablets with food and drink
Clarithromycin Accord film-coated tablets can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, do not take Clarithromycin Accord film-coated tablets without first consulting your doctor.
Driving and using machines
Clarithromycin Accord film-coated tablets may make you feel sleepy, dizzy or confused. If you experience these symptoms, do not drive or operate machinery.
Clarithromycin tablets contain sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.

3. How to take Clarithromycin Accord film-coated tablets

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents (aged 12 years and older)

• For lung infections, throat infections or sinusitis, skin and soft tissue infections: 250 mg twice daily. Your doctor may increase the dose to 500 mg twice daily in case of severe infections. The usual duration of treatment is 6–14 days.
• For the treatment of Helicobacter pylori infection associated with duodenal ulcers: Clarithromycin Accord film-coated tablets can be taken at a dose of 500 mg twice daily in combination with other medicines for the treatment of Helicobacter pylori. Your doctor will decide the most suitable treatment combination for you. If you are unsure which medicines to take and when to take them, speak to your doctor.

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

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

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

If you take more Clarithromycin Accord film-coated tablets than you should
If you accidentally take more tablets in one day than prescribed by your doctor, or if you think a child has accidentally swallowed any tablets, contact immediately your nearest hospital emergency department or your doctor. An overdose is likely to cause vomiting and stomach pain.
Take this patient information leaflet, any remaining tablets, and the medicine container with you to the hospital or doctor, so they can determine which and how many tablets have been taken.

If you forget to take Clarithromycin Accord film-coated tablets
If you forget to take a tablet, you may take it as soon as you remember, unless it is almost time for your next dose. Do not take more tablets than your doctor has prescribed. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Clarithromycin Accord film-coated tablets
Do not stop taking this medicine just because you feel better. It is important that you complete the full course of treatment prescribed by your doctor; otherwise, symptoms may return and the medicine may be less effective the next time it is used.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following conditions at any time during treatment,
STOP TAKING THE TABLETS and contact your doctor immediately:

• Severe and prolonged diarrhoea, with blood or mucus. Diarrhoea may occur more than two months after treatment with clarithromycin, in which case you should still inform your doctor.
• Rash, difficulty breathing, fainting, or swelling of the face and throat. These are signs 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 indicating 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 abdominal and back pain caused by inflammation of the pancreas.

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

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

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

• oral or vaginal thrush (a fungal infection)
• reduction in levels of certain blood cells (which may increase the likelihood of infections or increase the risk of bruising or bleeding)
• loss of appetite, heartburn, bloating, constipation, flatulence
• anxiety, restlessness, 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
• changes in liver enzyme levels, liver inflammation, impaired liver function, 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 the available data)

• skin swelling, redness, and itching. Sometimes brown scales and small palpable skin bleedings may appear, often accompanied by joint and abdominal pain (Henoch-Schönlein purpura). Contact a doctor immediately if a severe skin reaction occurs: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis)
• acne
• inflammation of the pancreas
• confusion, hearing loss, hallucinations (seeing things), altered sense of reality, and feelings of panic, depression, abnormal dreams or nightmares
• seizures (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 have myasthenia gravis (a condition in which muscles become easily weak and fatigued), clarithromycin may worsen these symptoms
• low blood sugar levels
• kidney inflammation or impaired kidney function (you may notice fatigue, swelling or puffiness of the face, abdomen, thighs, or ankles, or problems urinating) or kidney failure

Reporting of suspected adverse reactions
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 Claritromycin Accord film-coated tablets

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

6. Other information

What Claritromycin Accord contains

• Each Claritromycin Accord tablet contains 250 or 500 mg of the active substance clarithromycin.
• The other ingredients are:
  Tablet core: microcrystalline cellulose (E460), croscarmellose sodium, 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 Claritromycin Accord and contents of the pack
Claritromycin Accord 250 mg film-coated tablets are light yellow, oval-shaped, biconvex film-coated tablets, marked with "C1" on one side. The length of the 250 mg tablet is approximately 14.90 mm and the thickness approximately 7.10 mm.
Claritromycin Accord 500 mg film-coated tablets are light yellow, oval-shaped, biconvex film-coated tablets, marked with "C" and "2" on each side of the break line. The tablet can be divided into equal doses. The length of the 500 mg tablet is approximately 18.60 mm and the thickness approximately 8.85 mm.
Claritromycin Accord 250 mg film-coated tablets are available in blisters containing 10, 12, 14, 16, 20, 21, 30, 250 and 500 tablets. Claritromycin Accord 500 mg film-coated tablets are available in blisters containing 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,
The 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 European Economic Area Member States under the following names:

This leaflet was last approved on: 01/2025.