200 mg, 300 mg prolonged-release tablet er
theophylline
What Theo-Dur is and what it is used for
Theo-Dur contains the active substance theophylline, which relieves spasms in the muscles of the trachea, thereby dilating the trachea and reducing breathing difficulties. Theo-Dur is a special type of tablet, which slowly releases the active substance. Therefore, you only need to take Theo-Dur 2 times a day.
Theo-Dur is used for asthma and tracheal catarrh ( chronic bronchitis ) and spasms in the tracheal muscles in case of damage to the alveoli ( emphysema ).
Theophylline should not be used as a first-line treatment for asthma in children.
What you need to know before using Theo-Dur
Do not use Theo-Dur
- if you are allergic to theophylline or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Theo-Dur if you:
- have reduced liver function
- have cardiovascular disease
It is also important that you tell the doctor that you are using Theo-Dur if you get an infection, high fever, or use antibiotics. You should also contact your doctor if you intend to stop smoking while using Theo-Dur, as the dose may then need to be changed.
Other medicines and Theo-Dur
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines while taking Theo-Dur. Certain medicines/natural medicines can affect or be affected by the treatment with Theo-Dur, e.g.:
- Cimetidine (medicine for stomach ulcers )
- Ranitidine (medicine for stomach ulcers )
- Ticlopidine (medicine against, among other things, blood clots in the brain)
- Mexiletine (medicine for, among other things, irregular heart rhythm)
- Propafenone (medicine for, among other things, irregular heart rhythm)
- Adenosine (diagnostic aid)
- Propranolol (a drug for, among other things, high blood pressure )
- Verapamil (medicine for, among other things, high blood pressure )
- Erythromycin (medicine against bacterial infections)
- Ciprofloxacin (medicine against bacterial infections)
- Norfloxacin (medicine against bacterial infections)
- Rifampicin (a drug for tuberculosis )
- Isoniazid (a drug for tuberculosis )
- Aciclovir (medicine against viral infections)
- Ritonavir (medicine against viral infections)
- Methotrexate (medicine against, among other things, cancer)
- Interferon-alpha (drugs that stimulate the immune system)
- Allopurinol (medicine for, among other things, gout )
- Halothane (anesthetic)
- Ketamine (anesthetic)
- Phenobarbital (a drug for, among other things, epilepsy )
- Phenytoin (a drug for epilepsy )
- Diazepam (medicine for, among other things, anxiety)
- Fluvoxamine (medicine for, among other things, depression)
- Rofecoxib (medicine for, among other things, joint wear and tear)
- Disulfiram (withdrawal drug for alcohol abuse)
- St. John’s wort extract (included in some herbal remedies)
- Felodipine (medicine for high blood pressure and angina)
- Lithium (medicine for, among other things, manic depression)
- Glucagon (drug for very low blood sugar in diabetes )
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 using this medicine.
Pregnancy
No known risks when used during pregnancy.
Breast-feeding
Theophylline passes into breast milk but probably does not affect children who are breastfed. However, talk to your doctor about more than occasional use of Theo-Dur during breastfeeding.
Driving ability and use of machinery
Theo-Dur does not affect your ability to drive or use machines.
Theo-Dur contains lactose and sucrose
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
How to use Theo-Dur
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
Your doctor will determine the dose that is right for you.
The usual starting dose for adults is 300 mg 2 times a day.
Patients with more severe cardiovascular disease and impaired liver function may initially need a lower dose .
The tablets are divisible. Whole or divided tablets must not be chewed or crushed and must be swallowed with at least ½ glass of water.
Use for children
Theo-Dur prolonged-release tablets should not be used by children under 6 years of age. There are other forms of preparation of theophylline that are more suitable for children under 6 years of age.
If you have taken too much Theo-Dur
If you have ingested too large a dose of medicine, always contact a doctor or hospital for an assessment of the risk and advice.
The most common symptoms when you have taken too much are increased and irregular heartbeat and seizures.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
At very high theophylline concentrations in the blood, increased and irregular heart activity and convulsions may occur. In case of side effects of this kind, you should contact a doctor.
Common (May affect more than 1 in 100 users) : Nausea, vomiting, loss of appetite, tremors, sleep disturbances, irritability, nervousness, headache. These side effects usually disappear after a period of treatment or a change in dose .
Uncommon (May affect up to 1 in 100 users): Hives, skin rash.
Rare (May affect up to 1 in 1,000 users): Muscle cramps.
How Theo-Dur should be stored
Theo-Dur is stored at a maximum of 30 o C.
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is theophylline 200 mg and 300 mg respectively.
- Other ingredients are lactose 62.4 mg and 93.8 mg respectively, sugar spheres 70 mg and 105 mg respectively, hypromellose, magnesium stearate, glycerol monostearate, white wax, cetyl alcohol, myristyl alcohol, cellulose acetate phthalate and diethyl phthalate.
Other ingredients are included to give the prolonged-release tablets the right properties and so that they can be manufactured.
Appearance and package sizes of the medicine
Prolonged-release tablet er 200 mg: White, oval tablets with a score on one side and engraving THEO-DUR 200 on the other side.
Prolonged-release tablet er 300 mg: White, rod-shaped tablets with a score on one side and engraving THEO-DUR 300 on the other side.
Package sizes:
Plastic jar with child-resistant screw cap, 100 prolonged-release tablets
Marketing Authorisation Holder
Manufacturer
allphamed PHARBIL Arzneimittel GmbH, Göttingen, Germany