Document: Diclofenac Orifarm gel ENG PL change

• Diclofenac Orifarm gel PL
• Diclofenac Orifarm gel ENG PL

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Package leaflet: Information for the user

Diclofenac Orifarm, 11.6 mg/g gel

diclofenac diethylamin

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.

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

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

• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

What is in this leaflet

1. What Diclofenac Orifarm is and what it is used for

2. What you need to know before you use Diclofenac Orifarm

3. How to use Diclofenac Orifarm

4. Possible side effects

6. Contents of the pack and other information

Diclofenac Orifarm is a gel that contains diclofenac, which is a non-steroidal anti-inflammatory drug (NSAID). Diclofenac reduces pain and have an anti-inflammatory effect.

Diclofenac Orifarm is used for treatment of local pain of mild to moderate intensity in connection with inflammation or muscle- og joint injury.

Diclofenac Orifarm is only intended for cutaneous use.

You must talk to a doctor if you do not feel better or if you feel worse after 7 days.

Do not use Diclofenac Orifarm

- if you are allergic to diclofenac or any of the other ingredients of this medicine (listed in section 6).

- if you are allergic (hypersensitive) to acetylsalicylic acid or other NSAID.

- if you have a history of symptoms of asthma, urticaria (hives) or acute rhinitis (runny nose) after using acetylsalicylic acid or other NSAID.

- if you are more than 6 months pregnant.

- if you have damaged skin e.g. eczema, acne, infected skin, open wounds or burns.

- if you are younger than 14 years.

Warnings and precautions

Talk to your doctor,pharmacist or nurse before using Diclofenac Orifarm

- if you suffer from reduced kidney function, reduced heart function or reduced liver function.

- if you have an active peptic ulcer.

- if you are using other NSAID.

- if you are elderly, as the risk of side effects is higher.

- if you are exposed to direct sunlight or artificial sun as there is a risk of skin reactions. You should avoid sunlight or artificial sun during treatment and for two weeks after stopping treatment.

Contact with eyes and mucosa should be avoided. The gel must not be eaten.

The recommended treatment duration should not be exceeded because of the risk of side effects increases over time.

If you develop a rash at any time during treatment you should stop using Diclofenac Orifarm.

Diclofenac Orifarm is not intended for use with occlusive bandages. Joint strains can be supported by bandage, but the winding must not be so hard that the blood circulation is stopped.

Other medicines and Diclofenac Orifarm

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

Because Diclofenac Orifarm is used on the skin the absorption of diclofenac into the blood stream is low. Therefore the risk of interactions with other medicinal producs is small.

Use of Diclofenac Orifarm while using acetylsalicylic acid or other NSAID may increase the risk of side effects.

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 taking this medicine.

Pregnancy

You must not use Diclofenac Orifarm if you are more than 6 months pregnant.

Breastfeeding

Diclofenac passes into mother milk. However, effects on the baby seem unlikely with therapeutic doses for the mother. Diclofenac Orifarm should not be applied to the breasts or to large areas of skin if you are breast-feeding.

Driving and using machines

Diclofenac Orifarm does not affect the ability to drive or operate machinery.

Diclofenac Orifarm contains propylene glycol

Diclofenac Orifarm contains propylene glycol which may cause skin irritation.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you. Check with your doctor, pharmacist or nurse if you are not sure.

The recommended dose:

Adults and adolescents above the age of 14 years

Apply Diclofenac Orifarm gel 3-4 times a day. Massage the gel gently into the skin where the pain or inflammation is localised. The amount you need is dependent on the size of the area you are treating. Normally 2-4 g (corresponding to 6-12 cm gel) is sufficient. The maximum dose is 16 g per day. You may experience a slight cooling when the gel is rubbed in.

After use

Wash your hands after you have rubbed in Diclofenac Orifarm unless you intend to treat your hands.

Use in children

Diclofenac Orifarm is not recommended for children under 14 years of age.

Contact your doctor if your symptoms have not improved within 7 days.

If you use more Diclofenac Orifarm than you should

An overdose is unlikely to happen if you use more Diclofenac Orifarm than you should, because the absorption into the blood stream is low.

If you by accident swallow the gel you should contact your doctor or pharmacist.

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

4. Possible side effects

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

The side effects are often mild and reversible skin reactions at the treatment site. In rare cases allergic reactions can occur. If this happens you should stop using Diclofenac Orifarm and contact your doctor immediately.

Stop using Diclofenac Orifarm immediately if you experience swelling of the face, mouth, tongue or throath, which may also include breathing difficulties. Contact your doctor immediately if you experience these symptoms.

Common (may affect up to 1 in 10 people):

Rash, eczema, redness of the skin, dermatitis (including contact dermatitis), itching.

Uncommon (may affect up to 1 in 100 people):

Skin redness, point forned bleedings in the skin, allergic eczema, burning sensation at the treatment site.

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

Blisters on the skin (bullous dermatitis).

Very rare (may affect up to 1 in 10,000 people)

Blistering rash (pustular rash), hypersensitivity including urticaria, swelling of face, throat, tongue and eyes (angioedema) which may be serious and can include breathing difficulties, light sensitivity reactions, urticaria, dry skin, asthma, bronchospasm.

Not known (frequency cannot be estimated from the available data):

Severe allergic (anaphylactic) reactions which may be serious.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Diclofenac Orifarm

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

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

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

6. Content of the pack and other information

What Diclofenac Orifarm contains

• The active substance is: Diclofenac diethylamine 11.6 mg/g, which corresponds to 10 mg/g of diclofenac sodium.

• The other ingredients are: carbomers, cocoyl caprylocaprate, diethylamine, isopropyl alcohol, macrogol cetostearyl ether, liquid paraffin, propylene glycol and purified water.

What Diclofenac Orifarm looks like and contents of the pack

Diclofenac Orifarm is a white gel.

Pack sizes: Aluminium tubes of 50 g, 100 g or 2x100 g.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Orifarm Generics A/S

Energivej 15, POB 69

DK-5260 Odense S

Denmark

Email: info@orifarm.com

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark and Sweden Diclofenac Orifarm

This leaflet was last revised in 21 december 2015