Masagim 28.57mg/g 35g cream

Massagim 28.57 mg/g Cream

Diethylamine salicylate

This leaflet contains important information for you. Read it carefully.

This medicine can be acquired without a doctor's prescription. However, Massagim should be used with caution in order to obtain the desired results.

- Keep this leaflet. You may need to read it again.

- Ask your pharmacist if you need more information or advice.

- If the symptoms persist or worsen, talk to your doctor.

- If any of the side effects gets worse, or if you experience any side effects not listed in this leaflet, talk to your doctor or pharmacist.

In this leaflet:

l . What Massagim is and what it is used for

1. Before using Massagim
2. How to use Massagim
3. Possible side effects
4. How to store Massagim
5. Other information

1. WHAT MASSAGIM IS AND WHAT IT IS USED FOR

Pharmacotherapeutic group: 9.1.10 Musculoskeletal system. Non-steroidal antiinflammatory drugs. Non-steroidal anti-inflammatory drugs for topical use.

Massagim is indicated for:

- Mild to moderate muscle pain

- Contusions

- Post-traumatic pain

2. BEFORE USING MASSAGIM

Do not use Massagim

Massagim is contraindicated in the following situations:

-  If you are allergic (hypersensitive) to the active ingredient or to any of the other ingredients in Massagim

-  If you have a history of allergy (hypersensitivity) to salicylates or NSAIDs

-  Massagim should not be applied to mucous membranes, broken skin (wounds, burns? eyes, dermatoses or eczema.

-  Massagim should not be used on children.

Take special care with Massagim

Massagim should be used with caution:

-  In patients with glucose-6-phosphate-dehydrogenase (G6PD) deficiency

-  For long-term use in patients with impaired renal function

-  Over extensive areas of skin

Taking Massagim with other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding

Talk to you doctor or pharmacist before taking or using any medicine.

There are no data available on the use of diethylamine salicylate in pregnant women. There are no animal studies with respect to its effects on pregnancy, foetal/embryonic and post-natal development. The risks to humans are unknown.

There is insufficient information on the excretion of diethylamine salicylate in human or animal milk. A risk to nursing infants cannot be excluded. The decision whether to continue/discontinue breastfeeding or to continue/discontinue treatment with Massagim must take into account the benefit of breastfeeding for the child and the benefit of treatment with Massagim for the mother.

Driving and using machines

Massagim has no effect on the ability to drive and use machines.

Important information about some of the ingredients in Massagim

The container of this medicinal product contains latex rubber, which can cause severe allergic reactions.

Massagim contains lanolin, which can cause localised skin reactions (e.g. contact dermatitis).

Massagim contains methyl parahydroxybenzoate, which can cause allergic reactions (possibly delayed).

3. HOW TO USE MASSAGIM

For topical use only.

Dosage and method of administration Apply I to 3 times daily to the affected ar massaging gently.

If you use more Massagim than you should

At the recommended therapeutic doses, Massagim is generally well-tolerated. Systemic absorption of the drug is low. Greater systemic absorption only occurs in rare cases, such as when the drug is applied to broken skin. In this case, symptoms of salicylate overdose may occur (headache, dizziness, tinnitus, hearing difficulties, decreased visual acuity, mental confusion, lassitude, drowsiness, sweating, thirst, hyperventilation, nausea, vomiting and occasionally diarrhoea). If this occurs, the treatment should be discontinued and the patient should seek medical attention/hospital care immediately.

If you forget to use Massagim

If you forget a dose, apply the medicine as soon as you remember and resume the treatment according to the established schedule. If you have any questions, talk to your doctor or pharmacist.

Do not apply a double dose to make up for a dose you forgot to apply.

POSSIBLE SIDE EFFECTS

Like all medicines, Massagim can cause side effects, although not everybody gets them.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

Massagim produces a certain flushing effect, and warmth and redness are part of its therapeutic action. However, on some types of sensitive skin, an epidermal irritation may appear. This will disappear when the treatment is discontinued.

HOW TO STORE MASSAGIM

Store below 25 ⁰C.

Store tightly closed in the original container.

Keep out of the reach and sight of children.

Do not use Massagim after the expiry date printed on the tube and on the outer package. The expiry date corresponds to the last day of the month indicated.

Medicines should not be discarded in the plumbing or in the household waste. IYÍQyoui• pharmacist how to dispose of medicines you no longer need. These measures'Vill help protect the environment.

OTHER INFORMATION

What Massagim contains

- The active substance is: diethylamine salicylate. One gram of cream contains 28.57 mg of diethylamine salicylate.

-  The other ingredients are: stearic acid (vegetable source), lanette SX, cholesterol, trolamine, lanolin, glycerol, methyl parahydroxybenzoate, coumarin, lavender essential oil and purified water.

What Massagim looks like and the contents of the pack.

Massagim is supplied in the form of a cream packaged in an aluminium/epoxy lacquer tube sealed with a band of latex. Pack with a 35-gram tube of cream.

Marketing authorisation holder

Laboratórios Vitória, S.A.

Rua Elias Garcia, 28

2700-327 Amadora

Portugal