Tetramil - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Pheniramine (Pheniramine maleate), Tetrizoline (Tetrizoline hydrochloride)

TETRAMIL 0.3% + 0.05% eye drops, solution

Why is Tetramil used? What is it for?

TETRAMIL contains pheniramine maleate, a medicine to treat allergy (antihistamine) and tetrizoline, a medicine to relieve swelling (decongestant).

TETRAMIL is indicated in adults and adolescents aged 12 years and over for the treatment of:

  • Allergies and inflammation of the conjunctiva (a membrane of the eye), accompanied by excessive sensitivity to light, tearing, sensation of a foreign body in the eye, pain.

Talk to your doctor if you don't feel better or if you feel worse after 4 days.

Contraindications When Tetramil should not be used

Do not use TETRAMIL

  • if you are allergic to pheniramine maleate or tetrizoline hydrochloride to any of the other ingredients of this medicine (listed in section 6)
  • if you are allergic to some medicines to clear the nose (nasal decongestants) such as: xylometazoline, oximetazoline and tetrizoline
  • if you suffer from increased pressure of the fluid that is contained inside the eye (glaucoma)
  • if you have severe eye diseases
  • if you are pregnant (see section "Pregnancy and Breastfeeding")
  • if you are breast-feeding (see section "Pregnancy and Breastfeeding")
  • if you are taking medicines belonging to the class of monoamine oxidase inhibitors (used to treat depression) (see section "Tetramil and other medicines").

Do not use in children under 12 years of age.

Precautions for use What you need to know before taking Tetramil

Talk to your doctor or pharmacist before using TETRAMIL.

In particular, ask your doctor:

  • if you suffer from increased blood pressure (hypertension)
  • if you suffer from increased thyroid function (hyperthyroidism), which is a gland at the base of the neck.
  • if you have heart problems
  • if you suffer from raised blood sugar levels (diabetes)
  • if you suffer from infections or pus in the eye
  • if you have foreign bodies in your eye
  • if you have various eye problems (mechanical, chemical, heat)

Especially prolonged use of topical products can give rise to sensitization phenomena. In this case, stop the treatment and resort to suitable therapy.

If symptoms persist or worsen after a short period of treatment, consult your doctor. Prolonged use may give rise to inconveniences, do not use this medicine for more than 4 consecutive days, unless otherwise prescribed, as otherwise unwanted effects may occur.

Tetramil multi-dose bottle and contact lenses:

Do not use Tetramil multidose bottle if you wear contact lenses as it contains a preservative (merthiolate). Remove contact lenses before fitting and wait at least 15 minutes before putting them back in. In these cases you can use the single-dose container which does not contain preservatives.

Children

Do not use TETRAMIL in children between 0 and 12 years of age. (see section 2. Do not use TETRAMIL).

Interactions Which drugs or foods can modify the effect of Tetramil

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. In particular, tell your doctor if you are taking:

  • Medicines belonging to the class of monoamine oxidase inhibitors (used to treat depression) as the concomitant intake of these products may cause the onset of a severe increase in blood pressure, therefore concomitant administration is contraindicated.

Warnings It is important to know that:

Pregnancy and breastfeeding

Do not use this medicine if you are pregnant or breast-feeding. Ask your doctor for advice.

Driving and using machines

There are no known effects of TETRAMIL on the ability to drive and use machines.

TETRAMIL multidose bottle contains sodium ethyl mercuriothiosalicylate

It can cause allergic reactions.

Dosage and method of use How to use Tetramil: Dosage

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is: one or two drops to be applied in the eye 2-3 times a day. Do not exceed the recommended dose.

A higher dosage of the product even if taken locally and for a short period of time can give rise to serious undesirable effects affecting the whole organism (See section 4 "Possible undesirable effects").

Instructions for use of the multidose bottle

  1. To open, press the cap and unscrew at the same time.
  2. After use, close it by screwing it down tightly.

Instructions for use of the single-dose container

  1. Separate the container from the others
  2. Open the container by twisting and pulling the cap
  3. Use immediately after opening
  4. After use, throw away the container even if you have used it partially.

Overdose What to do if you have taken too much Tetramil

If you use more TETRAMIL than you should

If you use more TETRAMIL than you should, contact your doctor or go to the nearest hospital. The product, if accidentally ingested or if used for a long period in excessive doses, can cause toxic phenomena. Accidental ingestion of the drug, especially in children, can cause a reduction in the activity of the nervous system which can manifest itself with strong physical and mental relaxation (marked sedation, ie severe drowsiness), coma.

If you forget to use TETRAMIL

Do not use a double dose to make up for a forgotten dose.

If you stop taking TETRAMIL

If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Before stopping treatment, ask your doctor.

Side Effects What are the side effects of Tetramil

Like all medicines, this medicine can cause side effects, although not everybody gets them. During treatment with Tetramil you may experience allergic reactions, in this case STOP the treatment immediately, and contact your doctor who, if necessary, can give you appropriate treatment.

You may also experience the following side effects while being treated with TETRAMIL:

Effects affecting the eye

  • dilation of the pupil
  • increased pressure inside the eye

Effects that affect the whole organism

  • increased blood pressure (hypertension)
  • heart disease
  • increased blood sugar levels (hyperglycaemia)
  • nausea
  • headache

In children, if accidentally ingested, the preparation can cause a state of even profound drowsiness (drowsiness), and decreased activity (hypotonia).

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

Expiry and Retention

This medicinal product does not require any special storage conditions.

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

The multidose bottle should not be used more than 30 days after first opening the container. The single-dose container does not contain preservatives: after administration, throw the vial away even if you have only used it partially.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not use this medicine if you notice that the bottle or single-dose container is punctured and / or damaged.

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

Composition and pharmaceutical form

What TETRAMIL contains

Multidose bottle (100 ml of solution contain):

  • The active ingredients are: pheniramine maleate 0.3 g and tetrizoline hydrochloride 0.05 g
  • The other ingredients are: boric acid; borax; sodium ethylmercuriothiosalicylate (see section 2. TETRAMIL contains sodium ethylmercuriothiosalicylate), sodium carboxymethylcellulose, water for injections.

Single-dose container (100 ml of solution contain):

  • The active ingredients are: pheniramine maleate 0.3 g and tetrizoline hydrochloride 0.05 g
  • The other ingredients are: Boric acid; Borax; Water for injections

What TETRAMIL looks like and contents of the pack

TETRAMIL multi-dose bottle: dropper bottle containing 10 ml of clear and colorless solution.

TETRAMIL single-dose container: box containing 10 single-dose containers of 0.5 ml of clear and colorless solution enclosed in PE-Al sachets.

Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.

More information on Tetramil can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER 09 .0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, COMPLETE DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS AND QUALITY CONTROLS

01.0 NAME OF THE MEDICINAL PRODUCT

TETRAMIL

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

100 ml of solution contain:

Active principles:

Pheniramine maleate g 0.30.

Tetrizoline hydrochloride 0.05 g

For excipients see par. 6.1

03.0 PHARMACEUTICAL FORM

Eye drops, solution.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

In allergic and inflammatory states of the conjunctiva accompanied by photophobia, lacrimation, foreign body sensation, pain.


04.2 Posology and method of administration

Instill in the affected eye 1-2 drops 2-3 times a day. Do not exceed the recommended doses. Strictly follow the recommended doses. A higher dosage of the product even if taken topically and for a short period of time can give rise to effects serious systems.


04.3 Contraindications

Hypersensitivity to the components of the product or other closely related substances from a chemical point of view; in particular towards xylometazoline, oximetazoline, tetrizoline.

Narrow / closed angle glaucoma or other serious eye disease.

Contraindicated in children under the age of twelve.

Generally contraindicated during pregnancy and lactation (see par. 4.6).

Contraindicated in the simultaneous treatment with monoamine oxidase inhibitors (tranylcypromine, phenelzine, pargiline) (see par. 4.5).


04.4 Special warnings and appropriate precautions for use

The product, although presenting a very low systemic absorption, must be used with caution in subjects suffering from hypertension, hyperthyroidism, heart disorders, and hyperglycemia (diabetes).

In case of persistence or worsening of symptoms after a short period of treatment, invite the patient to consult the doctor.

In any case, the product should not be used for more than 4 consecutive days, unless otherwise prescribed, given the possibility that unwanted effects may otherwise occur.

The product, if accidentally ingested or if used for long periods in excessive doses, can cause toxic phenomena.

Infections, pus, foreign bodies in the eye, mechanical, chemical, heat damage require medical attention.

The use of topical products, especially if prolonged, can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy.

The multidose bottle contains merthiolate as a preservative which can give rise to sensitization reactions, and must not be applied while wearing contact lenses (in the case of contact lens wearers, wear the same only 15 minutes after using the product) In these cases it is possible to use the single-dose container which does not contain preservatives.


04.5 Interactions with other medicinal products and other forms of interaction

The concomitant intake of monoamine oxidase inhibitors can cause the onset of severe hypertensive crisis.


04.6 Pregnancy and breastfeeding

During pregnancy and breastfeeding, use only in case of real need, under the direct supervision of the doctor.


04.7 Effects on ability to drive and use machines

No effects are described.


04.8 Undesirable effects

The use of the product can sometimes cause pupillary dilation, systemic effects from absorption (hypertension, cardiac disorders, hyperglycaemia), increased intraocular pressure, nausea, headache.

In children, if accidentally ingested, the preparation can cause deep sleep and hypotonia.

Hypersensitivity phenomena may rarely occur. In this case, treatment must be interrupted and appropriate therapy instituted.


04.9 Overdose

The product, if accidentally ingested or if used for a long time in excessive doses, can cause toxic phenomena. Accidental ingestion of the drug, especially in children, can cause central nervous system depression: severe sedation (severe drowsiness), coma. If this happens, use gastric lavage and general supportive measures.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

S01GA52 Decongestant and antiallergic

Tetramil is a combination of a vasoconstrictor drug (Tetrizoline) with potent alpha-receptor stimulating activity and an antihistamine drug (Pheniramine) blocking H1 receptors.

Pharmacodynamic studies have shown how this association was found to be active in reducing the acute inflammatory reaction in the rabbit's eye following chemical and thermal stimuli. Thermal injury hyperemia was reduced by 51%, edema by 37%, hyperemia from chemical injury was reduced by 58%, edema by 44%.


05.2 "Pharmacokinetic properties

No pharmacokinetic data are available for the combination.


05.3 Preclinical safety data

In toxicology studies it was observed that rabbits treated for 30 days with Tetramil eye drops, 2 drops 8 times a day, at a concentration up to 9 times the human therapeutic dose, did not show toxic phenomena.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Boric acid; borax; sodium ethyl mercuriothio salicylate; sodium carboxymethylcellulose; water for injections.

Single-dose container:

boric acid; borax; water for injections.


06.2 Incompatibility

Incompatibilities with other medicines are unknown.


06.3 Period of validity

Multidose bottle:

4 years in intact packaging.

The product should not be used more than 30 days after first opening the container.

Single-dose container:

3 years in intact packaging.

The single-dose container does not contain preservatives: the product must be used immediately after opening the container which must be disposed of even if only partially used.


06.4 Special precautions for storage

None in particular.


06.5 Nature of the immediate packaging and contents of the package

Multidose bottle: 10 ml polyethylene dropper bottle.

Single-dose containers: box of 10 single-dose containers of 0.5 ml enclosed in PE-Al sachets.


06.6 Instructions for use and handling

Multidose bottle:

To open, press the cap and unscrew at the same time. After use, close it by screwing it down tightly.

Single-dose container:

Open the container by twisting and pulling the cap.

07.0 MARKETING AUTHORIZATION HOLDER

Alfa Wassermann S.p.A.

Registered office: Via E. Fermi, n.1 - Alanno (PE)

Administrative office: Via Ragazzi del "99, n. 5 - Bologna

08.0 MARKETING AUTHORIZATION NUMBER

TETRAMIL 0.3% + 0.05% eye drops, solution - 10 ml bottle - AIC n. 017863010

TETRAMIL 0.3% + 0.05% eye drops, solution - 10 single-dose containers of 0.5 ml - A.I.C. n. 017863034

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

08.11.1960 /01.06.2005

10.0 DATE OF REVISION OF THE TEXT

01/09/2007

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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