250 mg, 500 film-coated tablets 
Clarithromycin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

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

What Clarithromycin Aurobindo is and what it is used for

Clarithromycin Aurobindo belongs to a group of medicines called macrolide antibiotics. Antibiotics stop the growth of bacteria that cause infection .

Clarithromycin Aurobindo is used to treat the following infections:

  • Respiratory tract infections such as bronchitis and pneumonia,
  • Infection in the throat and sinuses,
  • infection in the skin and soft tissues,
  • ulcers of the stomach and duodenum caused by Helicobacter pylori.

Clarithromycin contained in Clarithromycin Aurobindo may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you use Clarithromycin Aurobindo

Do NOT take Clarithromycin Aurobindo:

  • if you are allergic to clarithromycin, any other macrolide antibiotics or any of the other ingredients of this medicine (listed in section 6).
  • if your heart rhythm is irregular (ventricular heart rhythm including torsades de pointes ) or if you have a heart problem (especially if you have a rhythm disorder such as prolonged QT interval )
  • if you suffer from severe liver failure and at the same time have impaired kidney function
  • if you are taking medicines containing terfenadine or astemizole (for hay fever or allergies ) or cisapride or pimozide tablets, as combination with these medicines can sometimes cause serious disturbances in the heart rhythm. Talk to your doctor about alternative medicines.
  • if you are taking other medicines that are known to cause severe heart rhythm disorders
  • if you have abnormally low levels of potassium in your blood ( hypokalaemia )
  • if you or someone in your family has a history of heart rhythm disturbances (ventricular arrhythmias , including torsade de pointes ) or an abnormal electrocardiogram ( ECG , curve showing electrical activity of the heart) called “long QT syndrome”
  • if you are taking medicines containing
  • ergotamine or dihydroergotamine (used to treat migraines )
  • simvastatin or lovastatin (for high cholesterol )
  • colchicine (for gout )
  • ticagrelor or ranolazine (to prevent stroke or heart attack)

Talk to your doctor before taking this medicine if you have now or before been affected by the above points.

Warnings and cautions

Talk to your doctor or pharmacist before taking Clarithromycin Aurobindo,

  • if you are allergic to lincomycin or clindamycin ( antibiotics )
  • if you have impaired liver or kidney function.
  • if you have or have had heart problems.
  • if you are pregnant (see Pregnancy, breast-feeding and fertility )
  • if you have abnormally low levels of magnesium in your blood (hypomagnesemia). Talk to your doctor before taking these tablets.
  • If you get severe or prolonged diarrhea (pseudomembranous colitis) during or after taking Clarithromycin Aurobindo, contact your doctor immediately. Inflammation of the bowel (pseudomembranous colitis) has been reported with almost all antibacterial drugs including clarithromycin.
  • if you have used clarithromycin before, several times, or over a long period of time.
  • Patients should be advised to discontinue treatment and consult their physician if they experience symptoms of hepatitis such as anorexia , jaundice, dark urine, itching or an upset stomach.
  • if you are taking a combination of clarithromycin and benzodiazepines, such as alprazolam, triazolam or midazolam (see “Other medicines and Clarithromycin Aurobindo”)
  • if you are taking other medicines that affect your hearing. Impaired hearing is examined during treatment and afterward.
  • In case of severe acute allergic reaction such as anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis , clarithromycin treatment should be discontinued immediately and appropriate treatment instituted as soon as possible.
  • You should not use clarithromycin concomitantly with lovastatin or simvastatin. (see “Do not take Clarithromycin Aurobindo”). You should also be careful when using clarithromycin with other statins. If you are also taking blood-thinning tablets at the same time as clarithromycin, there is a risk of severe bleeding.

If any of the above apply to you, talk to your doctor before taking Clarithromycin Aurobindo

Other medicines and Clarithromycin Aurobindo

Some other medicines may increase or decrease the effect of Clarithromycin Aurobindo or increase or decrease its effect of Clarithromycin Aurobindo.

Clarithromycin Aurobindo  may increase the effect of the following medicines:

  • astemizole, terfenadine (for allergies ), pimozide (for the treatment of mental disorders), cisapride (for stomach problems), ergotamine or dihydroergotamine (for the treatment of migraines ), lovastatin or simvastatin (cholesterol-lowering drugs) (see ‘Do not take Clarithromycin Aurobindo’)
  • alprazolam, triazolam, midazolam (facilitates falling asleep)
  • atorvastatin, rosuvastatin (lowers cholesterol)
  • warfarin, phenprocoumon (blood thinners): concomitant use may increase the risk of bleeding. Blood clotting (ability to coagulate) should be monitored more frequently if Clarithromycin Aurobindo is used at the same time as these medicines.
  • Nateglinide, repaglinide, or insulin (for diabetes )
  • carbamazepine, phenytoin, valproic acid (for epilepsy )
  • cilostazol (improves blood flow in the legs)
  • colchicine (for gout )
  • ciclosporin, sirolimus, tacrolimus (used after organ transplantation)
  • digoxin , verapamil, quinidine , disopyramide (heart medicines), concomitant use of clarithromycin with these medicines may cause arrhythmias in the heart.
  • methylprednisolone ( cortisone for the treatment of inflammation )
  • omeprazole (for stomach upset)
  • rifabutin ( antibiotic )
  • sildenafil, tadalafil, vardenafil (for the treatment of sexual dysfunction)
  • theophylline (for asthma )
  • tolterodine (for urinary incontinence)
  • vinblastine (for cancer)
  • drugs that can affect your hearing, especially aminoglycosides (a group of antibiotics given intravenously )
  • atypical antipsychotic drugs (eg quetiapine)

Both the effect of Clarithromycin Aurobindo and the effect of the following medicines may increase if taken together:

• atazanavir, saquinavir (for the treatment of HIV )

Itraconazole (for the treatment of fungal infections)

If your doctor has recommended that you take Clarithromycin Aurobindo at the same time as any of the medicines mentioned above, your health should be monitored extra closely.

Clarithromycin Aurobindo may reduce the effect of the following medicines:

• zidovudine (for treatment of HIV – infection ). To avoid this, take these medicines at an interval of four hours between them.

The following medicines may reduce the effect of Clarithromycin Aurobindo:

• rifampicin, rifabutin, rifapentine ( antibiotics )

• efavirenz, nevirapine, etravirine (for the treatment of HIV )

• phenytoin, carbamazepine, phenobarbital (for epilepsy )

• St. John’s wort (for depression)

The following medicines may increase the effect of Clarithromycin Aurobindo:

Ritonavir (for virus infection)

• fluconazole (antifungal)

The use of clarithromycin or other macrolide antibiotics at the same time as digoxin , quinidine , disopyramide or verapamil (heart medicine) may cause arrhythmias in the heart.

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

Pregnancy, breastfeeding and fertility

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

If you are pregnant or breast-feeding, do not take Clarithromycin Aurobindo before consulting your doctor.

Driving and using machines

Clarithromycin generally does not affect the ability to drive or use machines, but side effects such as drowsiness, dizziness, or confusion may occur. Use caution before driving or using machines before knowing how to react to this medicine.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Clarithromycin Aurobindo contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use Clarithromycin Aurobindo

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Clarithromycin Aurobindo can be taken with or without food.

Clarithromycin 500 mg film coated Aurobindo e tablets are not suitable for the dose to you 500mg. There are other options available in the market for this strength.

Recommendations of the usual dose are given below:

Adults including the elderly and adolescents (children over 12 years):

250 mg clarithromycin twice daily. In case of a more severe infection, your doctor may increase the dose from one to 
500 mg twice daily. The usual treatment time is 7-14 days and should continue for at least two days after the symptoms subside.

Treatment of adults with ulcers and sores on the duodenum caused by Helicobacter pylori

500 mg clarithromycin twice daily in combination with other medicines to treat Helicobacter pylori. Your doctor will prescribe the combination that is best for you.

Patients with kidney problems

If you have severe kidney problems, your doctor may halve your dose from the normal dose. In these cases, Clarithromycin Aurobindo should not be used for more than 14 days.

Use for children and adolescents

Children under 12 years

Clarithromycin Aurobindo tablets are not recommended for the treatment of children under 12 years of age (body weight below 30 kg). Your doctor will prescribe another medicine that is suitable for your child.

For children with bodyweight over 30 kg, the same dose is used as for adults.

If you have the impression that the effect of this medicine is too strong or too weak, talk to your doctor or pharmacist.

An overdose will most likely cause vomiting and stomach pain.

If you forget to take Clarithromycin Aurobindo

If you miss a dose, take it as soon as you remember, unless it is already time for the next dose. Do not take a double dose to make up for a forgotten dose. Take all of the following doses at your usual time, according to your original schedule.

If you stop using Clarithromycin Aurobindo

Do not stop taking this medicine just because you feel better without first discussing it with your doctor. It is important that you take the entire course of medication prescribed by your doctor, as infection may otherwise recur.

If you have any further questions on the use of this product, 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 get any of the following side effects at any stage of your treatment with Clarithromycin Aurobindo, stop taking the tablets and contact your doctor immediately:

  • allergic reaction with sudden difficulty breathing, speaking, or swallowing
  • severe dizziness or fainting
  • severe skin reactions, such as blistering of the skin, mouth, lips, eyes or genitals

Contact a doctor as soon as possible if you get the following symptoms:

  • severe or prolonged diarrhea, possibly with blood or mucus in the stool. These can be signs of severe inflammation of the intestines. Your doctor may terminate your treatment. Do not take medicines to reduce the movements of the intestinal functions.
  • Liver function with the following possible symptoms
    • loss of appetite
    • yellowish skin or whites of the eyes
    • pale stools, dark urine
    • skin irritation,
    • sore stomach
  • palpitations or irregular heartbeat
  • severe pain in the abdomen and back due to inflammation of the pancreas

Other possible side effects: 
Common adverse s (can occur in 1 in 10):

  • difficulty sleeping
  • headache
  • changed taste experiences
  • stomach upset, such as nausea, vomiting, stomach pain, indigestion or diarrhea
  • changes in liver function (which is noticeable in blood tests)
  • Rash
  • increased sweating.

Uncommon side effects  (affects 1 in 100 people):

  • cod in the mouth (fungal infection)
  • fungal infection of the abdomen
  • decreased number of certain white blood cells which may increase the risk of infection (leukopenia and neutropenia )
  • increased number of certain white blood cells (eosinophilia)
  • decreased appetite
  • anxiety, dizziness, difficulty sleeping, chills
  • dizziness
  • hearing loss or tinnitus
  • palpitation
  • inflammation of the stomach, mouth, or tongue
  • bloated stomach, constipation, flatulence ( flatulence )
  • dry mouth
  • cholestasis (stop in the bile duct)
  • increased amount of liver enzymes in the blood
  • itching, rash
  • muscle pain
  • general malaise
  • weakness
  • chest pain
  • overindulge
  • fatigue

No known frequency  (cannot be calculated from the available data): 

  • intestinal inflammation with severe diarrhea called Pseudomembranous colitis,
  • skin swelling and redness (rose fever), acne
  • sharp decrease in white blood cells with sudden high fever, severe sore throat, and mouth ulcers ( agranulocytosis )
  • unusual bruising or bleeding due to low platelet count
  • Severe allergic reaction that causes the face or throat to swell ( angioedema )
  • Psychosis, a feeling of loss of identity
  • confusion, change in perception of reality or panic
  • depression, nightmares, disorientation, hallucinations, mania
  • cramps
  • altered sense of smell, loss of sense of taste or smell
  • deafness
  • tingling or numbness of hands or feet
  • problem with blood coagulation
  • discoloration of teeth or tongue
  • acne
  • muscle pain or weakness in the muscles
  • kidney inflammation or kidney failure
  • unusual urine color

Contact a doctor immediately if you get a serious skin reaction: red, scaly rash with lumps under the skin and blisters (exanthematous pustulosis ). This side effect occurs in an unknown number of users (has been reported).

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects , you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

5. How to store Clarithromycin Aurobindo

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 carton and blister.

The expiration date is the last day of the specified month.

No special storage instructions.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is clarithromycin.

Each film-coated tablet contains 250 mg of clarithromycin 
Each film-coated tablet contains 500 mg of clarithromycin

  • The other ingredients are: microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, povidone, hypromellose, propylene glycol, titanium dioxide (E 171), hydroxypropyl cellulose, vanillin, sorbic acid, and yellow iron oxide (E 172)

What the medicine looks like and the contents of the pack

Film-coated tablet

Clarithromycin Aurobindo 250 mg film-coated tablets :

Light yellow, oval, biconvex, film-coated tablets with a “D” printed on one side and “62” on the other. The size is 15.1 mm x 7.1 mm

Clarithromycin Aurobindo 500 mg film-coated tablets

Light yellow, oval, biconvex, film-coated tablets with a “D” printed on one side and “63” on the other. The size is 18.5 mm x 8.1 mm

Clarithromycin Aurobindo 250 mg and 500 mg tablets are available in blister packs of 7, 12, 14, and 21 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

UK

or

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com 

Muhammad Nadeem

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