Coldistan nasal drops 10 ml

Coldistan nasal drops contain a vasoconstrictor substance, which reduces swelling of the nasal mucosa and inhibits nasal secretion, and an anti-allergic substance, which additionally inhibits allergic reactions.
The effect of Coldistan nasal drops begins after 10 minutes and lasts around 4 - 6 hours.
Coldistan nasal drops are used:

• for the symptomatic treatment of predominantly allergic swelling of the mucous membranes of the nose and throat, hay fever, runny nose due to hypersensitivity (vasomotor rhinitis), inflammation of the nasal sinuses.

If you have middle ear infections, your doctor can prescribe Coldistan to help reduce swelling in the Eustachian tube.

If you don't feel better or feel worse after 5 days, contact your doctor.

Contraindications

Coldistan must not be used

• if you are allergic to diphenhydramine, naphazoline or any of the other ingredients of this medicine (listed in section 6);
• in the case of inflammation and loss of the nasal mucosa, which is accompanied by dryness, crust formation and ulceration (rhinitis sicca);
• if you suffer from glaucoma (angle-closure glaucoma);
• after operations on the pituitary gland or after surgical procedures carried out through the nose or mouth;
• if you are also taking MAO inhibitors (medicines for depression) or have taken them within the last two weeks;
• of patients with epilepsy or with severe asthma.
• Coldistan nasal drops with dropper pipette: for small children under 2 years of age (see also section 3).
• Coldistan nasal drops with nebulizer: in children under 12 years of age (see also section 3).

Interactions

Using Coldistan with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
When two or more drugs are used, a mutual influence can occur in the sense of an increase or decrease in effects and side effects.

• Because of the risk of a blood pressure crisis, COLDISTAN nasal drops must not or should not be used at the same time as medicines that are prescribed against depression (MAO inhibitors).
• be used at the same time as other medicines prescribed for depression (tri- and tetracyclic antidepressants) (see “Coldistan must not be used”).
• The effect is increased when taking medication against Parkinson's disease (trihexyphenidyl) and medications that support circulation (adrenaline and norepinephrine) at the same time.
• Reduced effectiveness occurs when taken at the same time
  • some medications for gout or rheumatism/pain
  • Medication for cardiac arrhythmias
  • Substances that reduce blood clotting (coumarin preparations such as Macumar or Sintrom)
  • remedies against fungal infections
  • Antibiotics
  • Cortisone
  • Sleeping pills, anesthetics
• Any depressant effect on the central nervous system that may occur can be increased by alcohol, sleeping pills, tranquilizers (drugs that have an anti-anxiety and relaxing effect), narcotic painkillers and neuroleptics (drugs used to treat mental illnesses).
• Interactions can occur if you take medicines against high blood pressure (alpha and beta receptor blockers) and against increased intraocular pressure (glaucoma) at the same time.
• Narcotics (anaesthetics), medicines to dilate the pupils (atropine sulfate), medicines for the treatment of cardiovascular diseases (propanolol) or insulin (medication for diabetes) can, together with COLDISTAN nasal drops, increase the effect on the heart and circulation.
• The simultaneous use of theophylline (drug used to treat asthma) and its derivatives in high doses increases the side effects listed under point 4.
  COLDISTAN combined with guanethidine and reserpine (medicines used in blood pressure therapy) can lead to an increase in blood pressure

Pregnancy, breast-feeding 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.
COLDISTAN nasal drops should not be used during pregnancy or breastfeeding as their safe use has not been clearly established.
Naphazoline and diphenhydramine cross the placenta and can accumulate in breast milk.
No controlled studies have been carried out on the influence of naphazoline and diphenhydramine on fertility.

Ability to drive and use machines
Warning: This medicine can impair the ability to react and drive!
The sedative effects of diphenhydramine may impair the ability to drive and use machines.

Application

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.

Dosage:
Coldistan nasal drops with dropper pipette:
May only be given to children under 12 years of age if prescribed by a doctor.

Adults and adolescents over 12 years: 3 - 4 drops in each nostril 3 - 4 times daily.
Children (6 – 12 years): 1 drop in each nostril up to 4 times daily.
The use of Coldistan nasal drops with a dropper pipette is not recommended for children aged 2 - 6 years.
Coldistan nasal drops with a dropper pipette must not be used in small children under 2 years of age.

Coldistan nasal drops with nebulizer:
Adults and adolescents over 12 years: 1 - 2 sprays in each nostril 3 - 4 times daily.
Coldistan nasal drops with nebulizer must not be used in children under 12 years of age.

Method of use:
For dripping or spraying into the nose. For nasal use.
Clean your nose thoroughly (blowing your nose) before use.

Coldistan nasal drops with a dropper pipette:
Tilt your head back and drip the appropriate number of drops into each nostril using a dropper pipette. While doing this, close the other nostril with your finger and breathe in. By simultaneously turning the head, an even distribution of the agent on the mucous membrane is achieved. After use, rinse the dropper pipette with hot water to avoid contamination of the bottle contents. Then dry the dropper pipette with a clean cloth.
Coldistan nasal drops with nebulizer:
Remove the protective cap. Before using for the first time, operate the spray pump until the first spray occurs. The dosing sprayer is then immediately ready for use with each pump. With your head in an upright position, insert the spray head into each nostril, activate the spray pump and breathe in through your nose at the same time.

Duration of application:
The interval between individual administrations should not be less than 4 hours.
Treatment with COLDISTAN nasal drops should not be continued for longer than 7 days in adults and adolescents aged 12 years and over. Treatment with Coldistan nasal drops (dropper pipette) should not be continued for longer than 5 days in children aged 6 - 12 years. Coldistan nasal drops using a nebulizer must not be used in children under 12 years of age.
A break of at least 10 days must be taken before further treatment. Continuous treatment with COLDISTAN nasal drops must not be carried out.
Longer, uninterrupted use may cause habituation symptoms.

Side effects

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

Psychiatric illnesses

• Uncommon (affects 1 to 10 people in 1,000): Anxiety, insomnia, restlessness

Heart disease

• Rare (affects 1 to 10 people in 10,000): increased pulse rate, increased blood pressure, cardiac arrhythmias, palpitations

General disorders and administration site conditions

• Rare: nausea, headache, dizziness and tiredness

Not known (frequency cannot be estimated from the available data): A temporary burning sensation may occur after instillation/spraying into the nose. Approximately 6 hours after using Coldistan nasal drops, a brief increase in blood flow in the nose occurs, which can impair the normal activity of the cilia in the nose to varying degrees. Skin irritation is possible due to the preservative benzalkonium chloride.

Additional side effects in children
It can - especially in children - lead to a depression of the central nervous system with weakness, tiredness, slow heart rate, drop in body temperature, sweating, dizziness, cramps, loss of consciousness, sleep disorders and muscle tremors, especially in children come.

composition

The active ingredients are: naphazoline hydrochloride, diphenhydramine hydrochloride
1 ml contains: diphenhydramine hydrochloride 1.0 mg, naphazoline hydrochloride 0.5 mg
Coldistan nasal drops with dropper pipette: 1 ml corresponds to 25 drops of
Coldistan nasal drops with nebulizer: 1 spray = 0.14 ml

The other ingredients are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium monohydrogen phosphate dodecahydrate, sodium edetate, purified water

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