CLARITHROMYCIN MYLAN GENERICS

Package leaflet: Information for the patient

Clarithromycin Mylan Generics 250 mg film-coated tablets, 500 mg film-coated tablets

Clarithromycin
Generic medicine
Please read all of this leaflet carefully before 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, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. WHAT IS CLARITHROMYCIN MYLAN GENERICS AND WHAT IS IT USED FOR

Clarithromycin Mylan Generics belongs to a group of medicines called macrolide antibiotics and is
used to treat various types of infections in adults and children from 12 years of age. These include
infections of the skin and soft tissues or of the respiratory tract (nose, throat, chest, lungs).
Clarithromycin Mylan Generics may also be used (in combination with other medicines) to treat
Helicobacter pylori (H. pylori) infection in patients with duodenal ulcer.

2. WHAT YOU SHOULD KNOW BEFORE TAKING CLARITHROMYCIN MYLAN GENERICS

Do not take Clarithromycin Mylan Generics:

• if you are allergic to clarithromycin or to any other macrolide antibiotic, such as erythromycin, or to any of the other ingredients of this medicine (listed in section 6).
• if you are currently taking any of the following medicines:
• ergot alkaloids (e.g. ergotamine or dihydroergotamine) (for migraine)
• oral midazolam (a sedative)
• lovastatin or simvastatin (statins, for high cholesterol)
• colchicine (for gout)
• ticagrelor (to prevent blood clots)
• ranolazine (for angina)
• you are taking medicines called terfenadine or astemizole (for hay fever or allergies) or cisapride (for stomach disorders) or domperidone (for nausea (feeling unwell) and vomiting (feeling sick)) or pimozide (for psychiatric conditions), because the combination of these medicines may sometimes cause serious disturbances in heart rhythm
• you are taking other medicines known to cause serious disturbances in heart rhythm
• you have a history of heart rhythm disorders (ventricular arrhythmias including torsades de pointes) or abnormalities on the electrocardiogram (ECG, electrical recording of the heart) called long QT syndrome
• you have abnormally low levels of potassium or magnesium in the blood (hypokalaemia or hypomagnesaemia)
• you have severe liver failure in combination with kidney problems
• you are taking a medicine containing lomitapide

Warnings and precautions
Talk to your doctor or pharmacist before taking Clarithromycin Mylan Generics tablets if:

• you have kidney or liver problems
• you have coronary heart disease, severe heart failure or bradycardia (slow heart rate)

Other medicines and Clarithromycin Mylan Generics
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine, including those without a prescription, especially any of the following:

• digoxin, quinidine, verapamil, amlodipine, diltiazem or disopyramide (medicines for the heart)
• warfarin or any other anticoagulant, for example dabigatran, rivaroxaban, apixaban or other medicines that thin the blood
• ergotamine or dihydroergotamine (for migraine)
• carbamazepine, phenobarbital, valproate or phenytoin (medicines for epilepsy)
• theophylline (which helps breathing)
• terfenadine or astemizole (for hay fever or allergies)
• domperidone (for nausea (feeling unwell) and vomiting (feeling sick))
• triazolam, alprazolam or intravenous or oromucosal midazolam (sedatives)
• ibrutinib (an anticancer medicine)
• statins (e.g. atorvastatin, rosuvastatin, cerivastatin for high cholesterol levels)
• cisapride (for stomach disorders)
• cyclosporine, sirolimus or tacrolimus (immunosuppressants)
• pimozide, quetiapine or other medicines for psychiatric conditions
• zidovudine, ritonavir, atazanavir, saquinavir, etravirine, nevirapine or efavirenz (antiviral drugs for the treatment of HIV infection)
• rifabutin, rifapentine or rifampicin (for the treatment of certain infections)
• fluconazole or itraconazole (antifungals)
• St. John's wort (for depression)
• other antibiotics such as erythromycin
• colchicine (usually used for gout)
• insulin or oral antidiabetic medicines such as nateglinide or repaglinide (to reduce blood sugar levels)
• cilostazol (to improve blood circulation)
• methylprednisolone (anti-inflammatory)
• sildenafil, tadalafil or vardenafil (for erectile dysfunction)
• vinblastine (an anticancer medicine)
• tolterodine (for urinary incontinence)

Pregnancy and breastfeeding
Claritromycin Mylan Generics must not be given to pregnant or breastfeeding women unless the benefits to the mother outweigh the risks to the child.
Do not breastfeed your baby because small amounts of Claritromycin Mylan Generics may pass into breast milk.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Do not drive or operate machinery if you feel dizzy, confused or disoriented while taking this medicine.

Clarithromycin Mylan Generics contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. HOW TO TAKE CLARITHROMYCIN MYLAN GENERICS

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.

• The tablets should be swallowed whole with some liquid.
• The tablets may be taken with or without food.
• The 500 mg tablets must not be divided.

Recommended dose
For the treatment of respiratory, skin or soft tissue infections
Adults, elderly and children aged 12 years and over
The recommended dose is 250 mg twice daily. For severe infections, your doctor may increase the
dose to 500 mg twice daily. Treatment usually lasts between 6 and 14 days.

Use in children (under 12 years of age)
Do not administer this medicine to children under 12 years of age.

For the treatment of Helicobacter pylori infection in adults with duodenal ulcer
Clarithromycin Mylan Generics is usually used in combination with other medicines to treat H. pylori
infection in adults with duodenal ulcer. The dose and frequency of administration depend on the
other medicines prescribed by your doctor. It is important to take the medicine exactly as directed by your doctor.

If you take more Clarithromycin Mylan Generics than you should
Contact your doctor or the nearest hospital emergency department immediately. Take the
package and any remaining tablets with you. Signs of overdose may include feeling unwell (nausea or vomiting), diarrhoea, indigestion or stomach pain.

If you forget to take Clarithromycin Mylan Generics
Take the next dose as soon as you remember, unless it is almost time for your next dose.
Never take a double dose to make up for a forgotten dose.

If you stop taking Clarithromycin Mylan Generics
Continue taking the medicine for the full prescribed duration. Do not stop taking the
medicine just because you feel better. Stopping treatment too early may cause the infection to return.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If you experience any of the following adverse reactions, stop taking Claritromycin Mylan Generics and contact your doctor immediately or go to the nearest hospital emergency department:
Uncommon (may affect up to 1 in 100 people):

• allergic reaction with symptoms including severe itchy skin rash or swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing
• signs of infection, such as fever, chills, sore throat, fatigue, swollen glands, which may indicate a reduced number of white blood cells
• changes in heart rhythm, such as a fast or irregular heartbeat
• liver problems which may cause dark urine, pale stools, yellowing of the skin or whites of the eyes (jaundice), feeling unwell (nausea), weight loss, which may lead to liver failure.

Frequency not known (frequency cannot be estimated from the available data):

• severe abdominal or back pain caused by inflammation of the pancreas
• severe diarrhoea with blood in the stools
• severe skin reactions, including widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and extensive peeling of the skin affecting more than 30% of the body surface (toxic epidermal necrolysis)
• delayed allergic reaction with symptoms including skin rash, facial swelling, fever, swollen glands and abnormal blood test results (drug reaction with eosinophilia and systemic symptoms)
• changes in frequency and amount of urine, possible presence of blood in the urine, sometimes with back pain, rash, fever, feeling tired or weak, feeling generally unwell (these may be signs of kidney problems)
• fast heartbeat with chest pain and shortness of breath
• red, swollen skin caused by a bacterial infection
• hearing loss
• bruising or bleeding occurring more easily or more frequently than usual, which may indicate a reduced number of platelets in the blood
• muscle weakness, tenderness or pain with dark urine.

Contact your doctor immediately if you develop a severe skin reaction: a red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis). The frequency of this adverse reaction is not known (cannot be estimated from the available data).
These adverse reactions are serious and you may require medical attention.
Other possible adverse reactions
Common (may affect up to 1 in 10 people):

• feeling unwell (nausea), malaise, diarrhoea, indigestion, stomach pain
• headache
• changes in taste sensation, for example metallic or bitter taste
• difficulty sleeping
• skin rash
• increased sweating
• abnormalities in liver function tests, detectable by blood tests
• changes in levels of certain blood components that reflect your body's function, detectable by laboratory tests.

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

• vaginal infection
• dizziness, vertigo, anxiety, restlessness, drowsiness
• painful inflammation and swelling of the mouth or tongue (e.g. ulcers, cold sores)
• loss of appetite, constipation, dry mouth, flatulence, bloating, belching
• inflammation of the stomach (gastritis) with symptoms including pain, feeling unwell (nausea), vomiting, vomiting blood, blood in stools
• itching
• itchy skin rash with red, raised welts (urticaria)
• weakness, fatigue, chills, chest pain, general feeling of being unwell
• oral or vaginal candidiasis
• ringing in the ears (tinnitus), reduced hearing.

Very rare (may affect up to 1 in 10,000 people):

• nightmares.

Frequency not known (frequency cannot be estimated from the available data):

• mental health problems
• hallucinations (seeing or hearing things that are not real), abnormal dreams, depression, seizures, feeling dizzy, confusion or feeling detached from oneself and one's actions
• hyperactivity, feeling excited
• changes or loss of smell
• numbness, tingling or pins and needles sensation in arms and legs
• change in the colour of urine
• acne
• change in the colour of the tongue or teeth
• loss of taste sensation in part of the tongue
• joint or muscle pain.

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

5. HOW TO STORE CLARITHROMYCIN MYLAN GENERICS

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

6. PACK CONTENTS AND OTHER INFORMATION

What Claritromycin Mylan Generics contains
The active substance is clarithromycin. Each tablet contains 250 mg or 500 mg of clarithromycin.
The other components are: microcrystalline cellulose, pregelatinized corn starch, croscarmellose
sodium, povidone, anhydrous colloidal silica, stearic acid, magnesium stearate.
The coating contains: hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171),
macrogol (E1520), vanillin, quinoline yellow (E104).

Description of the appearance of Claritromycin Mylan Generics and pack contents
The medicine is presented as film-coated yellow oval tablets and is available in two strengths.
The 250 mg tablets are marked with “C250” on one side and “G” on the other; the 500 mg tablets are
marked with “C500” on one side and “G” on the other.
Claritromycin Mylan Generics is available in blisters and plastic bottles containing 4, 6, 7, 8, 10, 12,
14, 20, 21, 24, 28, 30, 42, 50, 60, 100, 250 or 500 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milano, Italy

Manufacturers
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin
13, Ireland
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Mylan Hungary Kft., H-2900 Komarom, Mylan utca 1, Hungary

This medicinal product is authorised in the European Economic Area countries under the
following names:
United Kingdom Clarithromycin
Greece Clarithromycin/Mylan TAB
Hungary Klarigen
Italy Claritromicina Mylan Generics
Slovakia Klaritromycin Mylan