Theophyllamine Meda – Theophylline uses, dose and side effects

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23 mg/ml solution 

for injection
theophylline

What Theophyllamine Meda is and what it is used for

Theophyllamine Meda contains the active substance theophylline, which relieves spasms in the muscles of the trachea, thereby widening the trachea and reducing breathing difficulties.

Theophyllamine Meda is used for acute pulmonary edema, asthma with spasms in the tracheal muscles, and in newborns with temporary pauses in breathing.

Theophylline contained in Theophylline Meda may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.

What you need to know before using Theophyllamine Meda

Do not use Theophylamine Meda

  • 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, pharmacist, or nurse before using Theophylline Meda if you

  • have cardiovascular disease
  • have reduced liver function
  • can suddenly suffer from a drop in blood pressure

Herbal medicines containing St. John’s wort should not be combined with Theophyllamine Meda. See section “Other medicines and Theophylline Meda”.

Other medicines and Theophyllamine Meda

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

Concomitant use of Theophyllamine Meda and certain medicines containing the following substances should be avoided:

  • Adenosine (diagnostic aid),
  • Cimetidine (medicine for stomach ulcers ),
  • Ketamine (anesthetic),
  • St. John’s wort extract (included in some (traditional) herbal medicines).

Theophylline Meda can affect or be affected by certain other medicines. Therefore, a dose adjustment may be required in case of simultaneous use of medicines containing the following substances:

  • Aciclovir (medicine against viral infections),
  • Allopurinol (medicine for, among other things, gout ),
  • Ciprofloxacin (medicine against bacterial infections),
  • Diazepam (medicine for, among other things, anxiety),
  • Disulfiram (withdrawal drug for alcohol abuse),
  • Erythromycin (medicine against bacterial infections),
  • Phenobarbital (medicine against, among other things, epilepsy ),
  • Phenytoin (medicine for epilepsy ),
  • Fluvoxamine (a drug for, among other things, depression),
  • Halothane (anesthetic),
  • Interferon-alpha (medicine that stimulates the immune system),
  • Methotrexate (medicine against, among other things, cancer),
  • Mexiletine (medicine against, among other things, irregular heart rhythm),
  • Norfloxacin (medicine against bacterial infections),
  • Propafenone (medicine for, among other things, irregular heart rhythm),
  • Ranitidine (medicine for stomach ulcers, heartburn, and acid reflux),
  • Rifampicin (a drug for tuberculosis ),
  • Ritonavir (medicine against viral infections),
  • Ticlopidine (medicine against, among other things, blood clots in the brain),
  • Verapamil (medicine against, among other things, high blood pressure ).

Theophyllamine Meda can be affected by certain medicines that contain the following substances when used simultaneously:

  • Isoniazid (a drug for tuberculosis ),
  • Lansoprazole (medicine for stomach ulcers, heartburn, and acid reflux),
  • Propranolol (medicine against, among other things, high blood pressure ),
  • Rofecoxib (medicine against, among other things, joint wear and tear).

Pregnancy, breastfeeding, and fertility

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 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.

Driving ability and use of machinery

Theophyllamine Meda does not affect your ability to drive or use machines.

Theophyllamine Meda contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per glass ampoule, i.e. it is almost “sodium-free”.

How to use Theophylamine Meda

The medicine is given intravenously (into a vein) by a doctor or nurse. Your doctor will determine the dose that is right for you.

If you have used too much Theophyllamine Meda 

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, always contact a doctor or hospital for an assessment of the risk and advice.

If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.

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, the treatment must be stopped immediately.

Common (may affect up to 1 in 10 users): Nausea, vomiting.

Uncommon (may affect up to 1 in 100 users ): Skin rash.

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

How Theophyllamine Meda should be stored

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

Store in the outer carton.

Light sensitive.

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 the 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.
  • Other ingredients are sodium chloride and water for injections.

Appearance and package sizes of the medicine

Glass ampoule 10 x 10 ml

Marketing authorization holder and manufacturer

Meda AB

Box 906

170 09 Solna

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