PHYLLOCONTIN FORTE CONTINUS 350 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take phyllocontin continus or phyllocontin forte continus tablets

Do not take Phyllocontin Continus or Phyllocontin Forte Continus tablets if you:

• are allergic (hypersensitive) to theophylline, aminophylline or any of the other ingredients of the tablets (see section 6 ‘Further Information’);
• have porphyria (a rare disease of the blood pigments).

Do not give to your child if they under 6 months of age or if they are also taking a cough medicine or if they are less than 6 years of age (or less than 22 kg) and taking a decongestant containing ephedrine.

Warnings and precautions

• Talk to your doctor, pharmacist or nurse before taking these tablets if you: have an irregular heartbeat, high blood pressure or other heart problems;
• experience worsening of chest symptoms e.g. breathlessness or cough
• have an over-active or under-active thyroid gland (hyper/hypothy­roidism);
• have a stomach ulcer;
• have liver problems;
• have cystic fibrosis;
• suffer from seizures, fits or convulsions;
• are unwell with a high temperature or fever;
• have a viral infection;
• are addicted to alcohol;
• are male and have difficulty in passing urine (for example, due to an enlarged prostate gland)
• smoke, as smoking may alter the way your tablets work.

Other medicines and Phyllocontin Continus or Phyllocontin Forte Continus tablets

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

• certain other medicines to treat

asthma or breathing conditions that contain theophylline, aminophylline, salbutamol, terbutaline or salmeterol, as you may need additional monitoring;

• steroids;
• diuretics to increase urine production;
• oral contraceptives;
• a herbal remedy called St John’s Wort (also known as Hypericum perforatum);
• aminoglutethimide, methotrexate or lomustine to treat cancer;
• carbamazepine or phenytoin to treat seizures, fits or convulsions;
• medicines known as barbiturates to help you sleep;
• adenosine, diltiazem, isoprenaline, mexiletine, propafenone, propranolol or verapamil to treat high blood pressure and other heart problems;
• regadenoson or dipyridamol used in heart problems;
• pentoxifylline to treat diseased blood vessels;
• medicines known as benzodiazepines, which are used as a sedative or to treat anxiety;
• aciclovir to treat Herpes viruses;
• sulphinpyrazone or allopurinol to treat gout;
• carbimazole to treat problems with your thyroid gland;
• cimetidine or nizatidine to treat stomach ulcers, indigestion or heartburn;
• certain antibiotics such as ciprofloxacin, clarithromycin, erythromycin, enoxacin;
• fluconazole to treat fungal infections;
• rifampicin or isoniazid to treat tuberculosis;
• ritonavir to treat HIV;
• medicines known as interferons, which you may be taking to treat conditions such as herpes, cancer, leukaemia or hepatitis;
• thiabendazole to treat worms such as threadworms;
• fluvoxamine or lithium to treat depression;
• disulfiram to treat alcoholism;
• cough medicines or decongestants containing ephedrine

Also tell your doctor or pharmacist if:

• you are going to have an operation, as these tablets may interact with certain anaesthetics such as halothane;
• you have recently had, or are going to have a flu injection.

Phyllocontin Continus or Phyllocontin Forte Continus tablets and alcohol

Alcohol can alter the way these tablets work. Please consult your doctor if you intend to drink alcohol whilst taking these tablets.

Pregnancy and breastfeeding

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

3. how to take phyllocontin continus and phyllocontin forte continus tablets

Two different strengths of tablets are available. Your doctor will decide which strength of tablet will suit you best. Always take these tablets exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.

Swallow your tablets whole with a glass of water. Do not crush or chew them.

Phyllocontin Continus and Phyllocontin Forte Continus tablets are designed to work properly over 12 hours. If a tablet is crushed or chewed the entire 12-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose.

You should take your tablets every 12 hours. For instance, if you take a tablet at 8 o’clock in the morning, you should take your next tablet at 8 o’clock in the evening.

Adults

The recommended starting dose for adults is one 225 mg tablet every 12 hours. After a week your doctor may increase your dose, depending upon how you respond to treatment. If you are elderly your doctor may suggest a lower dose.

Different doses will also be required if you have certain other medical conditions. Your doctor may ask you to have regular blood tests to ensure you are taking the correct dose.

Use in children

The required dose for children will depend on their weight, age and the severity of their breathing problems. This should be discussed with your doctor, pharmacist or nurse.

Do not exceed the dose recommended by your doctor. Check with your doctor, pharmacist or nurse if you are not sure.

If you take more Phyllocontin Continus or Phyllocontin Forte Continus tablets than you should or if someone accidentally swallows your tablets

Call your doctor or hospital straight away. People who have taken an overdose may have stomach pains and feel or be sick (possibly vomiting blood). They may also have a fast or irregular heartbeat, low blood pressure, feel very restless, experience overactive reflexes or unusual muscle stiffness, have a fit or even go into a coma. These symptoms may appear up to 12 hours after the overdose. When seeking medical attention make sure that you take this leaflet and any remaining tablets with you to show the doctor.

If you forget to take Phyllocontin Continus or Phyllocontin Forte Continus tablets

If you remember within 4 hours of the time your tablet was due, take your tablet straight away. Take your next tablet at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Phyllocontin Continus or Phyllocontin Forte Continus tablets You will probably take these tablets for a long time. Do not stop taking them unless your doctor tells you to, even if you feel better.

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

4. possible side effects

Like all medicines, these tablets can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions have been reported in rare cases. Tell your doctor immediately if you get any sudden wheeziness, difficulties in breathing, swelling of the eyelids, face or lips, rash or itching especially those covering your whole body.

The following side effects have been reported in patients treated with these tablets:

• Feeling sick.
• Headache.
• Dizziness.
• Vomiting, abdominal pain, diarrhoea, heartburn or gastrintestinal disorders (e.g. upset stomach).
• Difficulty in sleeping, feeling restless, irritable and shaky.
• A fast, slow or irregular heart beat.
• Difficulty in passing urine (especially in men) or passing increased amounts of urine.
• Increased uric acide levels in the blood, which could cause painful, swollen joints.
• Seizures, fits or convulsions.
• Rash or itchy skin.

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: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. how to store phyllocontin continus and phyllocontin forte continus tablets

Keep these tablets out of the sight and reach of children.

Do not use these tablets after the expiry date, which is stated on the outer carton and label or blister pack after ‘EXP’. The expiry date refers to the last day of that month.

Do not store your tablets above 25oC.

Do not take your tablets if they are broken or crushed as this can be dangerous and can lead to serious problems such as overdose.

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

6. contents of the pack and other information

What Phyllocontin Continus and Phyllocontin Forte Continus tablets contain

The active ingredient is aminophylline hydrate. Each tablet contains 225 mg or 350 mg of aminophylline hydrate.

The other ingredients are:

• Hydroxyethylce­llulose
• Povidone
• Magnesium stearate
• Cetostearyl alcohol
• Macrogol
• Talc
• Hypromellose (E464)
• Titanium dioxide (E171)
• Iron oxide (E172)

tablets look like and the contents of the pack

Phyllocontin Continus tablets are pale yellow, film-coated tablets marked NAPP on one side and SA on the other.

Phyllocontin Forte Continus tablets are pale yellow, film-coated tablets marked NAPP on one side and SA 350 on the other.

In each box there are 56 tablets.

Marketing Authorisation Holder and Manufacturer

The tablets are made by

Bard Pharmaceuticals Limited for the marketing authorisation holder Napp Pharmaceuticals Limited, both at Cambridge Science Park, Milton Road, Cambridge CB4 0GW, UK.