Document: Roxi Stada film-coated tablet ENG PL change

• Roxi Stada film-coated tablet PL
• Roxi Stada film-coated tablet ENG PL

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Package leaflet: Information for the user

Roxi Stada 150 mg film-coated tablets

Roxi Stada 300 mg film-coated tablets

roxithromycin

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.

What is in this leaflet

1. What Roxi Stada is and what it is used for

2. What you need to know before you take Roxi Stada

3. How to take Roxi Stada

4. Possible side effects

5. How to store Roxi Stada

6. Contents of the pack and other information

1. What Roxi Stada is and what it is used for

Roxi Stada film-coated tablets contain the active ingredient roxithromycin. Roxithromycin belongs to a group of medicines known as macrolide antibiotics. These are medicines used to fight infections caused by bacteria.

Roxi Stada is used to

• treat urinary tract infections caused by a certain bacterium.

• treat the following diseases in people who cannot take a type of medicine called beta-lactam antibiotics:

• infection/inflammation of the tonsils (tonsillitis)

• infection/inflammation of the throat (pharyngitis)

• sudden middle ear infection (acute otitis media)

• skin and soft tissue infections caused by bacteria, such as boils (furunculosis), skin infections (pyodermia, impetigo and erysipelas).

2. What you need to know before you take Roxi Stada

DO NOT take Roxi Stada

• if you are allergic to roxithromycin or any of the other ingredients of this medicine (listed in section 6).

• if you are allergic (hypersensitive) to other similar antibiotics of the macrolide type

• if you are also taking any of the following medicines:

• cisapride (used to treat acid reflux)

• ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) used to treat migraine

• pimozide (used to treat serious mental disorders)

• astemizole and terfenadine (antihistamines used for hay fever)

• if you were born with a heart condition called long QT syndrome

• if you have a family history of long QT syndrome. Your doctor will check for long QT syndrome using a heart recording called an ECG.

• if you have developed a heart condition called QT interval prolongation

Warnings and precautions

Talk to your doctor before taking Roxi Stada if you have or have had any medical condition, especially the following:

• if you have migraine headaches and are taking ergot alkaloids (such as ergotamine and dihydroergotamine)

• if your heart muscle does not get enough blood (coronary heart disease)

• if you have a history of irregular heart beats (ventricular arrhythmias)

• if you have an imbalance in the salt (electrolyte) or fluid level of your body. This includes:

• a low level of potassium in the blood (hypokalaemia)

• a low level of magnesium in the blood (hypomagnesaemia)

• if you have slow heart beat (bradycardia) of less than 50 beats per minute

• if you are taking medicines which can cause a heart condition called long QT syndrome, e.g.:

  • quinidine, procainamide, disopyramide, dofetilide, amiodarone (used to treat heart problems)

  • citalopram, tricyclic antidepressants (used to treat depression/mood disorders)

  • methadone (used to treat drug addiction)

  • antipsychotic medicines (e.g. phenothiazines)

  • medicines used to treat bacterial infections (antibiotics) belonging to a group called fluoroquinolones, e.g. moxifloxacin

• if you have a disease that is treated with medicines called protease inhibitors (e.g. telaprevir)

• if you are taking medicines which are used to treat fungal infections (e.g. ketoconazole, fluconazole, pentamidine)

• If you have a mild-moderate liver disease

• if you have severe liver disease you should normally not take Roxi Stada. For example, if you have a scarred and fibrous liver (cirrhosis) together with:

• inflamed liver (hepatitis) or

• a build up of fluid in the abdomen (ascites). See also section 3, How to take Roxi Stada.

However, your doctor may decide that you must take Roxi Stada to deal with your infection. In this case, your dose will be decreased.

Your doctor will check your liver function regularly if:

• you have signs of liver disease

• you have suffered from poor liver function after taking roxithromycin before

If your liver function gets worse during treatment, your doctor may tell you to stop taking Roxi Stada.

Pseudomembranous colitis: This is an infection causing inflammation of the large intestine. It can result in severe runny stools (diarrhoea) which can last for days or weeks, and can occur during or after treatment. If you have these symptoms:

• you should stop taking Roxi Stada immediately and see your doctor

• do not take medicines that slow down the normal passage of food through your system.

Your doctor will prescribe another medicine to treat your symptoms.

Allergic (hypersensitivity) reactions: Some patients have had serious allergic reactions when taking roxithromycin. Reactions include a serious allergic reaction called anaphylaxis. Symptoms of anaphylaxis may include swelling of the skin, of the face, limbs, tongue or throat, and breathing difficulties. Occasionally these reactions can be life threatening. If you have an allergic reaction:

• stop taking Roxi Stada

• contact your doctor or go to your nearest hospital immediately

Irregular heartbeat (arrhythmia): If you develop signs of an irregular or rapid heartbeat during treatment:

• stop taking Roxi Stada

• see your doctor immediately. He will check your heartbeat by making a recording (ECG).

A disorder causing muscle weakness (myasthenia gravis): If you suffer from myasthenia gravis your symptoms of myasthenia gravis may get worse. This may affect your breathing muscles and your breathing may get dangerously weak. If your symptoms get worse you should stop taking Roxi Stada and see your doctor immediately.

Children and patients weighing less than 40 kg: Roxi Stada should not be used by:

• children under 6 years

• patients with a body weight of less than 40 kg.

Blood and urine testing: If you need to take Roxi Stada for longer than two weeks your doctor will regularly check:

• your kidney function

• your liver function

• your blood

Other medicines and Roxi Stada

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

DO NOT take Roxi Stada if you are already taking any of these drugs (see Section 2).

• cisapride (used to treat night-time heartburn)

• ergot alkaloids (such as ergotamine and dihydroergotamine) used to treat migraine headaches

• pimozide (used to treat mental disorders like schizophrenia)

• astemizole and terfenadine (used to treat hay fever)

The effect of your Roxi Stada medicine can be affected by or can affect the following medicines:

• ciclosporin (used to prevent rejection of organ transplants)

• midazolam (a sedative medicine used for its calming effect and to reduce anxiety)

• anticoagulants (used to thin the blood, e.g. warfarin)

• cardiac glycosides (heart stimulants, e.g. digoxin)

• disopyramide (a heart medicine)

• theophylline (used to treat asthma and lung disease)

• bromocriptine (used to treat Parkinson disease and diseases in which a decrease of a specific hormone (prolactin) is indicated)

• rifabutin (used to treat tuberculosis)

• medicines which can cause a heart condition called long QT syndrome, e.g.:

  • quinidine, procainamide, disopyramide, dofetilide, amiodarone (used to treat heart problems)

  • citalopram, tricyclic antidepressants (used to treat depression/mood disorders)

  • methadone (used to treat drug addiction)

  • antipsychotic medicines (e.g. phenothiazines)

  • medicines used to treat bacterial infections (antibiotics) belonging to a group called fluoroquinolones, e.g. moxifloxacin

• if you have a disease that is treated with medicines called protease inhibitors (e.g. telaprevir)

• if you are taking medicines which are used to treat fungal infections (e.g. ketoconazole, fluconazole, pentamidine)

• simvastatin or other statins (medicines used to lower the cholesterol)

Oral contraceptives: You should note that the oral contraceptive pill may be less effective when you take Roxi Stada.

Roxi Stada with food and drink

You should take Roxi Stada at least 15 minutes before a meal which ensures that your body absorbs the medicine rapidly. Take Roxi Stada with something to drink, e.g. a glass of water.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Studies in animals have not shown any harmful effects of Roxi Stada. However, the use of Roxi Stada in pregnant or breast-feeding women has not been studied.

If you are pregnant, only use Roxi Stada if your doctor indicates it is absolutely necessary.

Breast-feeding

Roxithromycin passes into breast milk. If you are breastfeeding, only use Roxi Stada if your doctor indicates it is absolutely necessary.

Driving and using machines

When taking Roxi Stadadizziness and visual disturbance can occasionally occur. If you experience these symptoms you must not drive or use machines.

Roxi Stada contains milk sugar (lactose)

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Roxi Stada

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

You should take Roxi Stada tablets at least 15 minutes before a meal with some liquid, e.g. water.

Adults, the elderly, and children weighing at least 40 kg

The recommended dose is 150 mg Roxi Stada twice a day (every 12 hours).

If you are being treated for pneumonia your doctor may tell you to take 300 mg Roxi Stada once a day.

If you have kidney or liver problems

If you have impaired kidney function your Roxi Stada dose will not need to be adjusted.

If you have mild to moderate liver disease your doctor will decide if you must take Roxi Stada or not.

If you have severe liver disease you should normally not take Roxi Stada. For example, if you have a scarred or fibrous liver (cirrhosis of the liver together with:

• inflamed liver (hepatitis) or

• build up of fluid in the abdomen (ascites).

However, your doctor may decide that you must take Roxi Stada to deal with your infection. In this case, you will be given half of the usual dose per day. i.e. 150 mg roxithromycin.

Children

Children below 6 years of age should not use Roxi Stada tablets. Different forms of roxithromycin are available for young children. For example an oral suspension.

Duration of treatment

Your doctor will tell you for how long you should take Roxi Stada. For some infections treatment will last for at least 10 days.

You will usually be asked to take Roxi Stada for a further 3 or 4 days after your symptoms have improved.

It is important to always take the tablets for as long as your doctor tells you to.

If you take more Roxi Stada than you should

If you have taken too many tablets contact your doctor or a pharmacist.

Remember to take the package and any remaining tablets with you.

Overdose with Roxi Stada may cause the following symptoms:

• feeling sick (nausea)

• being sick (vomiting)

• runny stools (diarrhoea)

• headache

• dizziness

Your doctor will treat the symptoms of Roxi Stada overdose.

If you forget to take Roxi Stada

If you forget to take a dose of Roxi Stada, just take the next dose at the usual time. Do not take a double dose to make up for the missed one.

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.

Once-daily dosing (1 x 300 mg Roxi Stada tablets) gives more side effects than twice-daily dosing (2 x 150 mg Roxi Stada tablets).

Stop taking the medicine and contact your doctor immediately if you get:

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

Rare (may affect up to 1 in 1,000 people):

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

• Toxic epidermal necrolysis (TEN). This may cause a red rash over many parts of the body and loss of the outer layer of skin

• Stevens-Johnson syndrome, which may cause a red or purplish rash that spreads and blisters, eventually causing the top layer of your skin to die and shed. Other symptoms include fever, chills, headaches and tiredness.

Roxi Stadacan also cause the following side effects:

Please consult your doctor in regular intervals as requested. This will help to detect possible side effects. Please inform your doctor during the routine examination, if you experience or experienced a possible side effect.

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

• Feeling sick (nausea)

• Pain in the upper middle part of the abdomen (epigastric pain)

• Headache

• Dizziness

• Upset stomach (dyspepsia)

• Runny stools (diarrhoea)

• Rash

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

• Being sick (vomiting)

• Severe constipation (obstipation)

• Wind (flatulence)

• Changes in liver function as shown by blood tests (increased liver enzyme levels)

• Redness of the skin

• Hives (urticaria)

• Increase of certain white blood cells, detected by blood test (eosinophilia)

Rare (may affect up to 1 in 1,000 people):

• Changes in blood count

• Allergic (hypersensitivity) reactions such as anaphylaxis

• Taste disorders (dysgeusia) including loss of sense of taste (ageusia)

• Smell disorders (parosmia) including loss of sense of smell (anosmia)

• Wheezing or difficulty in breathing (bronchospasm)

• Failure of bile to flow from the liver properly. This causes build up of bile in the liver and liver damage (cholestatic hepatitis)

• Sudden inflammation of the liver (hepatitis)

• Inflammation of the pancreas (pancreatitis)

• A skin disease with redness, itching and flaking of the skin (eczema)

• Weakness

• Discomfort

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

• Infections with resistant bacteria or fungi (if you take Roxi Stada long-term)

• A reduced number of platelets in the blood (thrombocytopenia)

• Confusion

• Seeing or hearing things that are not there (hallucinations)

• Mental disorder where you lose contact with reality (psychosis)

• Pins and needles (paraesthesia)

• Problems with your sight (visual disturbance)

• Irregular heartbeat (QT prolongation)

• Rapid heartbeat (ventricular tachycardia)

• Problems with conduction of the heartbeat (torsades de pointes)

• Loss of appetite (anorexia)

• Yellowing of the skin or the whites of the eyes (jaundice)

• Itching (pruritus)

• A nerve disorder causing muscle weakness (myasthenia gravis)

• Low number of white blood cells (neutropenia)

• Purple or red pinpoint spots in the skin or mucous membranes caused by minor haemorrhage (purpura)

• Transitory deafness

• Impaired hearing (hypoacusis)

• A feeling of dizziness or “spinning” (vertigo)

• Ringing in the ears (tinnitus)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below) By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Roxi Stada

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

Do not store Roxi Stada above 30 °C.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Roxi Stadacontains

The active substance is roxithromycin.

One Roxi Stada 150 mg film-coated tablet contains 150 mg roxithromycin.

One Roxi Stada 300 mg film-coated tablet contains 300 mg roxithromycin.

The other ingredients in the tablet core are:

• Microcrystalline cellulose

• Anhydrous colloidal silica

• Croscarmellose sodium

• Polaxamer 188

• Povidone

• Talc

• Magnesium stearate

The other ingredients in the film coating are:

• Lactose monohydrate

• Hypromellose

• Macrogol 4000

• Titanium dioxide (E171)

What Roxi Stada150 mg and 300 mg film-coated tablets look like and contents of the pack

Roxi Stada 150 mg film-coated tablets are white, with an off-white core, round and biconvex in shape and bevelled.

Roxi Stada 300 mg film-coated tablets are white, with an off-white core, oblong and capsule-shaped, with a break line on one side.

The tablet can be divided into equal doses.

Roxi Stada film-coated tablets are packaged in PVC/aluminium blister packs containing:

150 mg tablets

300 mg tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

ALIUD Pharma GmbH & Co.KG

Gottlieb-Daimler-Straße 19

DE-89150 Laichingen

Germany

Manufacturer:

STADA Arzneimittel AG

Stadastraße 2 – 18

61118 Bad Vilbel

Germany

This leaflet was last revised in 2015-12-16