150 mg and 300 mg hard capsules
tetracycline
What Tetralysal is and what it is used for
Tetralysal is an antibiotic that prevents the growth of bacteria in case of infection. Tetralysal is used for acute worsening of chronic bronchial catarrh, certain pneumonia, chlamydial infections, and acne (pimples) on the face.
Lymecycline contained in Tetralysal may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Tetralysal
Do not use Tetralysal
- if you are allergic to lymecycline (converted to tetracycline in the body), other tetracyclines, or any of the other ingredients of this medicine (listed in section 6).
- in case of simultaneous treatment with vitamin A-based drugs (oral retinoids ) such as e.g. isotretinoin, etretinate, and acitretin (medicines for severe acne and psoriasis ).
Warnings and precautions
Talk to your doctor or pharmacist before using Tetralysal if:
- Do you have any kidney damage or kidney disease
- you have myasthenia gravis (a disease that weakens the muscles)
- you have systemic lupus erythematosus
Hypersensitivity to strong sunlight may occur and sunbathing and UV radiation (including solariums) should therefore be avoided during treatment.
Stop taking Tetralysal and contact your doctor immediately if you experience any of the following symptoms:
- swelling of the face, tongue, or throat, difficulty swallowing, hives, and difficulty breathing ( angioedema )
- headache with visual disturbances and vomiting/nausea as this may indicate increased pressure in the head
Children
Children under the age of 8 should only be treated with Tetralysal in exceptional cases because there is a risk that this type of medicine ( tetracyclines ) can cause damage to their bones and discolor their teeth.
Other medicines and Tetralysal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. The treatment effect can be affected if this medicine is taken at the same time as certain other medicines. Treating doctors, therefore, need to be aware of such concomitant medication.
The following medicines can be affected or affect the effect of Tetralysal:
- vitamin A-based medicines (oral retinoids ) such as isotretinoin, etretinate, and acitretin (medicines for severe acne and psoriasis ), or medicines with high doses of vitamin A (medicines for vitamin A deficiency).
- antacids (medicines against stomach acid).
- didanosine (medicine against viruses ).
- quinapril (medicine for high blood pressure ).
- coumarin-type anticoagulants (blood-thinning medicines).
Tell your doctor if you are being treated with lithium, as this medicine can increase lithium levels.
The following medicines should be taken at least 3 hours apart in combination with Tetralysal:
- iron tablets
- calcium
- zinc
- sucralfate
Tetralysal with food and drink
Tetralysal can be taken with a meal. The effect of Tetralysal may be slightly reduced if it is taken at the same time as calcium-containing products such as milk. There should be at least 3 hours between intake of Tetralysal and milk products.
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 using this medicine.
Pregnancy
Risk of harmful effects to the fetus. Therefore, do not use Tetralysal during pregnancy other than on a specific prescription from a doctor.
Breast-feeding
Tetralysal passes into breast milk. Breastfeeding must be discontinued during treatment with Tetralysal because there is a risk that the child will suffer damage to the skeleton and discolored teeth.
Driving ability and use of machinery
No effects have been observed.
Tetralysal 150 mg capsules contain lactose
If you have an intolerance to certain sugars, you should consult your doctor before taking this medication.
How to use Tetralysal
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Carefully tear open the aluminum packaging (strip) and take out the capsule.
The dose is determined by the doctor who adjusts it individually for you.
The recommended dose for adults is 300 mg morning and evening.
The capsules must be swallowed whole with at least ½ glass of water in an upright position (not lying down) to avoid damage to the esophagus. It is I essential at the entire course is completed, otherwise, the infection may flare up again.
If you have used too much Tetralysal
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to use Tetralysal
Do not take a double dose to make up for a missed dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 users):
- Nausea
- Abdominal pain
- Diarrhea
- Headache
Gastrointestinal complaints can be alleviated by taking capsules with food.
Has been reported (occurring in an unknown number of users):
- Blood effects
- Visual disturbances*
- Inflammation of the tongue
- Intestinal inflammation
- Vomiting
- Pain in the upper part of the abdomen
- Fever
- Jaundice
- Inflammation of the liver
- Allergic reaction with fever, rash, swelling, and sometimes drop in blood pressure
- Swelling of the face, lips, tongue, or throat, sometimes with shortness of breath or difficulty swallowing, so-called angioedema, see Warnings and precautions
- Skin rash, itching, or hives
- Liver effects
- Dizziness
- Increased pressure in the head
- Skin reactions caused by increased photosensitivity
- Skin and mucous membrane changes (sometimes serious)
- Depression
- Nightmares.
* Occurrence of clinical symptoms in the form of visual disturbances or headache may be due to increased pressure in the brain ( intracranial hypertension ), see Warnings and precautions.
The following side effects have been reported during treatment with tetracyclines (the group of drugs to which Tetralysal belongs):
- Discoloration of the teeth and underdevelopment of the tooth enamel when treating children under 8 years of age.
- Blood effects.
- Kidney effects can be enhanced if diuretics are used at the same time as tetracyclines.
- Benign increased pressure in the brain ( intracranial hypertension) with possible symptoms of headache, vomiting, and visual disturbances, including blurred vision, scotoma (dark spots or flickering lights in the field of vision ), diplopia (double vision), or a permanent visual impairment, have been reported in association with tetracycline your.
- There have been cases of systemic lupus erythematosus and pancreatitis that have generally been associated with treatment with tetracyclines.
If any side effects get worse or if you notice any side effects not mentioned in this information, contact your doctor or pharmacist.
How to store Tetralysal
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton after “Exp. dat.”. 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 memedicationshat that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
150 mg capsule
- The active substance is lymecycline, equivalent to 150 mg of tetracycline per capsule.
- Other ingredients are gelatin, magnesium stearate, leveling, corn starch, lactose, titanium dioxide (E 171), erythrosine (E 127), and quinoline yellow (E 104).
300 mg capsule
- The active substance is lymecycline, equivalent to 300 mg of tetracycline per capsule.
- Other ingredients are gelatin, magnesium stearate, leveling, titanium dioxide (E 171), erythrosine (E 127), quinoline yellow (E 104), and indigo carmine (E 132).
Appearance and package sizes of the medicine
Pack size: 20 pcs, 100 pcs
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Galderma Nordic AB
Seminariegatan 21
752 28 Uppsala
phone: 018-444 0330
fax: 018-444 0335
e-mail: nordic@galderma.com
Manufacturer
Inpac AB
Box 15
S-221 00 Lund
Laboratoires Sophartex
21 rue de Pressoir
BP 129
28501 VERNOUILLET Cedex, France
Laboratoires Galderma
ZI – Montdésir
74540 Alby-sur-Chéran, France