iMerckSerono

Package leaflet: Information for the user

Slo-Phyllin 60 mg, 125 mg & 250 mg Capsules

Theophylline (anhydrous)

The name of your medicine is Slo-Phyllin 60 mg, 125 mg & 250 mg Capsules, which will be referred to as Slo-Phyllin throughout this leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you.

-    Keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    If you get any side effects, talk to your doctor, pharmacist or nurse.

This includes any possible side effects not listed in this leaflet. See section 4.

-    You must talk to your doctor if you do not feel better or if you feel worse.

What is in this leaflet

1.    What Slo-Phyllin is and what it is used for

2.    What you need to know before you take Slo-Phyllin

3.    How to take Slo-Phyllin

4.    Possible side effects

5.    How to store Slo-Phyllin

6.    Contents of the pack and other information

1.    What Slo-Phyllin is and what it is used for

Theophylline (the active ingredient in Slo-Phyllin) belongs to a group of medicines called bronchodilators which relax and widen the airways of your lungs

Slo-Phyllin is used for:

•    breathing problems caused by asthma (either to treat your symptoms or to prevent you having an attack)

•    other chest illnesses (such as persistent bronchitis) Slo-Phyllin is specially made so that the active ingredient is released slowly over time to give you prolonged help. This is known as a prolonged release formulation.

2.    What you need to know before you take Slo-phyllm

Do not take Slo-Phyllin

•    if you are allergic to theophylline, to substances called ‘xanthines* (theophylline-like drugs), or to any of the other ingredients in this medicine (see list of ingredients in section 6)

•    if you are a child and are taking ephedrine (found in some cough medicines and decongestants)

•    if you have recently had a heart attack

•    if you develop a sudden, increased heart rate

•    Slo-Phyllin must not be used in children under 6 months of age.

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Slo-Phyllin

•    if you suffer from seizures (fits) or have had them in the past

•    if you have a long term heart or liver problem

•    if you have a viral infection

•    if you have suffered from alcoholism

•    if you have a stomach ulcer

•    if you have an irregular heart beat

•    if you have high blood pressure

•    if you have an overactive thyroid

•    if you have a kidney problem

•    if you have a rare blood disorder called porphyria

•    if you are taking another medicine which you know contains a xanthine-related substance

•    if you smoke or drink coffee or alcohol (this can affect the way your body uses theophylline)

•    if you have a fever (high temperature)

Other medicines and Slo-Phyllin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your Slo-Phyllin dosage, or the dosage of the other medicine, may need to be adjusted and the levels of theophylline in the blood may need to be monitored. Especially:

•    barbiturates (sedatives used to treat sleeping problems, anxiety or epilepsy)

•    benzodiazepines such as diazepam (used to treat anxiety or difficulty in sleeping)

•    carbamazepine, phenytoin, primidone (used to treat epilepsy)

•    lithium, fluvoxamine, viloxazine (used to treat depression)

•    disulfiram (used to treat alcoholism)

•    rifampicin, erythromycin, imipenem, fluoroquinolones, quinolones such as ciprofloxacin, enoxacin, clinafloxacin (antibiotics)

•    ritonavir or acyclovir (antivirals)

•    sulphinpyrazone, allopurinol (used to treat gout)

•    cimetidine or ranitidine (used to treat ulcers)

•    corticosteroids or steroids (used to treat various conditions including rheumatism, arthritis, allergic conditions, certain skin diseases, asthma or certain blood disorders)

•    aminoglutethimide (an anti-steroid used to treat Cushing’s syndrome and breast cancer)

•    isoniazid (isonicotinic acid hydrazide) (used to treat tuberculosis)

•    diltiazem, isoprenaline, verapamil, propafenone, mexiletine, adenosine (used to treat heart problems)

•    ticlopidine (used to prevent stroke)

•    beta-blockers such as propranolol (used to treat high blood pressure and anxiety)

•    alpha-interferon (often used to treat certain cancers or hepatitis)

•    rofecoxib (which was used to treat arthritis, but is no longer available)

•    pentoxifylline (used to treat circulation disorders and vascular dementia)

•    oral contraceptives (the birth control pill)

•    thiabendazole (used to treat worms)

•    influenza vaccine (the flu shot) or BCG (tuberculosis) vaccine

•    phenylpropanolamine (used in certain cough and cold remedies)

•    beta2 agonists, zileuton, zafiriukast (used to treat asthma)

•    halothane (a general anaesthetic)

•    diuretics (water tablets), such as frusemide/furosemide

•    St John’s wort (‘Hypericum perforatum’, a herbal remedy)

•    other medicinal products that contain xanthines, beta-sympathomimetics, caffeine and similar substances

Pregnancy and breast-feeding

Slo-Phyllin is not recommended for pregnant women in their first trimester and should only be taken during the second and third trimesters if the doctor considers it absolutely necessary, as theophylline can cross the placenta.

Dose reduction may be necessary if Slo-Phyllin is taken during pregnancy. Contractions can be inhibited if Slo-Phyllin is taken towards the end of pregnancy.

Newborn babies should be momtored carefully for the effects of theophylline, if Slo-Phyllin is taken during pregnancy. Slo-Phyllin should be used with caution in breast-feeding mothers, as theophylline is excreted in breast milk. If necessary, breast-feeding should take place immediately before administration of Slo-Phyllin and the infant should be carefully monitored for any effects of theophylline. If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Slo-Phyllin can affect the ability to react, and therefore you should take extra care when driving, using machinery, and when working at heights or without sure footing. The effect will be worsened if Slo-Phyllin is taken with alcohol or other medicines that can also affect the ability to react

Slo-Phyllin contains sucrose

This product contains sucrose. 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 Slo-Phyllin

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

Recommended dose

Adults

The usual starting dose is 250 mg twice daily.

Children under 6 years

Slo-Phyllin should not be used in children below 6 years of age. Other dosage forms are available that are more suitable for children aged less than 6 years.

Children aged 6-12 years

The usual starting dose is 120 mg twice daily

Children over 12 years

The usual starting dose is 250 mg twice daily

These are doses that your doctor will normally prescribe at the beginning of your Slo-Phyllin treatment.

The doctor may later need to increase the number of capsules you are taking.

Method of Administration

Slo-Phyllin is usually taken twice a day, in the morning and evening.

Swallow the capsules with a drink of water.

If you find swallowing the capsules difficult, open the capsule carefully and empty the pellets onto a spoonful of soft food such as yoghurt. Do not suck or chew the capsules or pellets. This would affect the prolonged release properties of Slo-Phyllin.

Blood Tests

The doctor will probably take blood samples to measure your theophylline level so that they can decide on how much Slo-Phyllin you need. Your blood level may need to be re-checked every 6 or 12 months.

If you take more Slo-Phyllin than you should

It is important that you contact your doctor or go to your hospital casualty department straightaway and tell them that you have taken too much theophylline. You may experience the side effects mentioned in section 4 of this leaflet ‘Possible side effects’. Seizures, a sudden drop in blood pressure, fast/irregular heart beat, loss of consciousness, muscle pain/weakness or severe gastrointestinal symptoms (such as gastrointestinal bleeding) could occur in severe cases.

If you forget to take Slo-Phyllin

Skip the missed dose and keep to your dose schedule by taking the next dose at the normal time.

Do not take a double dose to make up for a forgotten capsule.

If you atop taking Slo-Phyllin

Talk to your doctor before you stop taking the capsules and follow their advice.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4.    Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects with Slo-Phyllin, STOP taking the capsules and contact your doctor Immediately; A severe allergic reaction, such as itching, swelling of the face, lips, tongue, mouth or throat which may cause shortness of breath, wheezing or difficulty breathing. If you experience palpitations (abnormal heartbeats) speak to your doctor Immediately.

The following can occur, more severely at higher doses:

*    stomach problems (irritation, nausea, vomiting, discomfort, acid reflux particularly at night, diarrhoea)

*    dizziness

*    headache

*    tremors

*    convulsions

*    changes in heart rhythm, decreased blood pressure

*    the need to pass water frequently or increased urine output

*    a feeling of agitation or restlessness

*    difficulty felling asleep

*    low blood levels of potassium; increased blood levels of calcium, creatinine, sugar or uric acid

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at ww.mhra.gQY.Hk/ydlowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Slo-Phyllin

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 after “EXP’.

The expiry date refers to the last day of that month.

Do not store above 25’C. Store in the original package. 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 Slo-Phyllin contains

The active substance in this medicine is theophylline. Slo-Phyllin capsules* are made in three strengths containing GO mg theophylline, 125 mg theophylline or 250 mg theophylline.

The other ingredients are: sucrose, maize starch, refined bleached shellac and talc. The gelatin capsules for all 3 strengths contain titanium dioxide (E171). Red and black iron oxide (E172) are used to colour the 125 mg capsule.

Erythrosine (E127) and indigo carmine (E132) are used to colour the 250 mg capsule.

Printing ink contains: black iron oxide (E172), shellac glaze, propylene glycol.

What Slo-Phyllin looks like and contents of the pack

Slo-Phyllin 60 mg are white prolonged release capsules filled with small white pellets.

Slo-Phyllin 125 mg are brown prolonged release capsules filled with small white pellets.

Slo-Phyllin 250 mg are purple prolonged release capsules filled with small white pellets.

Slo-Phyllin is available in packs of 56 capsules

*DIFFUCAPS - Trademark of Adare Pharmaceuticals

S.r.I

Marketing Authorisation Holder and Manufacturer

Merck Serono limited, Bedfont Cross, Stanwell Road, Feltham, Middlesex, 1W14 8NX,UK.

This leaflet was last revised in June 2016

TW1065847    MCKLT03-5