DICLOFENAC AL

DICLOFENAC AL Pain Gel 10 mg/g

Important notes (mandatory information)

Diclofenac AL Pain Gel 10 mg/g. Active ingredient: Diclofenac sodium. Areas of application: for adults for the local, symptomatic treatment of mild to moderate, acute muscle pain, pain from acute sprains, strains or bruises resulting from blunt trauma and for adolescents from 14 years of age for the local, symptomatic treatment of pain from acute sprains, strains or bruises resulting from blunt trauma.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Diclofenac AL Pain Gel 10 mg/g, gel for use in adults and adolescents from 14 years of age
Active ingredient: Diclofenac sodium

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3–5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS DICLOFENAC AL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING DICLOFENAC AL?
3. HOW SHOULD DICLOFENAC AL BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD DICLOFENAC AL BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS DICLOFENAC AL AND WHAT IS IT USED FOR?

Diclofenac AL contains the active ingredient diclofenac, which belongs to the group of non-steroidal anti-inflammatory drugs (NSAIDs) and has analgesic and anti-inflammatory effects. It relieves pain and reduces inflammation and swelling in painful conditions of the joints and muscles. It is intended for external use (i.e. it is applied to the skin of the affected area of the body). Diclofenac AL is used in adults for the local, symptomatic treatment of mild to moderate, acute muscle pain, pain from acute sprains, strains or bruises resulting from blunt trauma. Diclofenac AL is used for the short-term treatment of adolescents from 14 years of age for the local, symptomatic treatment of pain from acute sprains, strains or bruises resulting from blunt trauma.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING DICLOFENAC AL?

Diclofenac AL must NOT be used:

• if you are allergic to diclofenac, propyl–4–hydroxybenzoate, methyl–4–hydroxybenzoate or any of the other ingredients of this medicine listed in section 6.
• if you have had an allergic reaction (e.g. asthma, bronchospasm, urticaria, runny nose or angioedema) in the past after taking/using acetylsalicylic acid or other NSAIDs (non-steroidal anti-inflammatory drugs).
• in the last trimester of pregnancy.
• by children and adolescents under 14 years of age.

Warnings and precautions

If you apply Diclofenac AL to a large area of skin and use it over a long period of time, the occurrence of systemic side effects cannot be ruled out. If you have asthma, hay fever, nasal mucosa swelling (so-called nasal polyps), chronic bronchoconstrictive (obstructive) respiratory diseases, chronic respiratory infections (especially those associated with hay fever-like symptoms) or hypersensitivity to other pain relievers and antirheumatic drugs, you are more at risk of asthma attacks (so-called analgesic intolerance/analgesic asthma), local skin or mucous membrane swelling (so-called Quincke's oedema) or hives than other patients when using Diclofenac AL. If you suffer from such conditions, you may only use Diclofenac AL under certain precautions (emergency preparedness) and direct medical supervision. The same applies if you are also allergic to other substances, such as with skin reactions, itching or hives. Diclofenac AL is a medicine for external use on the skin. Diclofenac AL should only be applied to healthy skin (not to open skin wounds or open injuries). Mucous membranes (e.g. in the mouth) or eyes must not come into contact with Diclofenac AL. It must not be taken orally. Stop treatment if a rash develops after using Diclofenac AL. Areas of skin treated with Diclofenac AL should not be exposed to sunlight. You can use a permeable (non-occlusive) dressing when applying Diclofenac AL to the skin. Do not use an airtight occlusive dressing.

Children

Precautions should be taken to prevent children from touching areas of skin that have been rubbed in.

Use of Diclofenac AL together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Since the systemic absorption of diclofenac is very low when applied topically, interactions are very unlikely.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

You must not use Diclofenac AL in the last trimester of pregnancy, as it could harm the unborn child or cause complications during childbirth. In the first 6 months of pregnancy, Diclofenac AL should only be used after consulting a doctor and the dose should be kept as low and the duration of treatment as short as possible.

Breastfeeding

Diclofenac passes into breast milk in small amounts. Diclofenac AL should only be used during breastfeeding after consulting a doctor. In this case, the medicine should not be applied to the breasts of nursing mothers and not to other large areas of skin or over a long period of time.

Driving and using machines

Diclofenac AL has no or negligible influence on the ability to drive and use machines.

Diclofenac AL contains propyl-4-hydroxybenzoate, methyl-4-hydroxybenzoate and propylene glycol

Propyl-4-hydroxybenzoate and methyl-4-hydroxybenzoate can cause hypersensitivity reactions, including delayed reactions. Propylene glycol can cause skin irritation.

3. HOW SHOULD DICLOFENAC AL BE USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

Adults and adolescents from 14 years of age

Apply Diclofenac AL thinly to the affected areas of the body 3 to 4 times a day as needed and rub in gently. Depending on the size of the area to be treated, a cherry- to walnut-sized amount, corresponding to 2 - 4 g of gel (20 - 40 mg diclofenac sodium), is required. The maximum total daily dose is 16 g of gel corresponding to 160 mg of diclofenac sodium. Wash your hands after use, unless they are the area to be treated. The duration of use depends on the area of application and the response to treatment. It is recommended that the course of treatment be reviewed 7 days after commencement. If the symptoms have not improved or have worsened after 3 - 5 days, a doctor should be consulted. If this medicine is needed for pain relief for more than 7 days or if the symptoms worsen, consult a doctor.

Children and adolescents under 14 years of age

Diclofenac AL must not be used in children and adolescents under 14 years of age, as there is insufficient data on the safety and efficacy in this patient group (see section 2, "Diclofenac AL must not be used").

Elderly people

No special dose adjustment is required. If you are over 65 years of age, you should pay particular attention to side effects when using it and, if necessary, consult a doctor or pharmacist.

Patients with impaired liver or kidney function

No dose adjustment is required.

In case of accidental contact with Diclofenac AL

Do not apply Diclofenac AL to injured or infected skin. If the eyes, mucous membranes (e.g. in the mouth) or injured areas of skin accidentally come into contact with the medicine, rinse the affected area with running water.

In case of accidental or intentional ingestion of Diclofenac AL

If you or your child have accidentally swallowed Diclofenac AL, contact your doctor or pharmacist immediately or go to a hospital. Take the packaging and the tube with you.

If you have used more Diclofenac AL than you should

Due to the low absorption of diclofenac into the bloodstream with limited topical application, an overdose is unlikely.

If you forget to use Diclofenac AL

Do not use double the amount to make up for the missed application.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Stop using Diclofenac AL immediately and see your doctor immediately if you experience any of the following side effects (may affect up to 1 in 10,000 people):

• Hypersensitivity, a type of allergic reaction, accompanied by rash (skin rash with redness), shortness of breath and difficulty swallowing.
• wheezing, shortness of breath or tightness in the chest (asthma).
• Swelling, especially of the face, lips and throat (angioedema).

The risk of these side effects is apparently greater at the start of treatment and in most cases these side effects occurred in the first month of treatment.

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

• Skin rash.
• Skin disease (eczema).
• Skin redness (erythema).
• Inflammation of the treated skin areas, which manifests itself as a rash, swelling or nodule formation (dermatitis, contact dermatitis).
• Itching (pruritus).

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

• extensive skin changes with redness, scaling and formation of large blisters (bullous dermatitis).

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

• Skin rash with pustules (pustular rash).
• increased sensitivity of the skin to sunlight (photosensitisation).

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

• Burning at the site of application, dry skin.

If Diclofenac AL is applied to a large area of skin and used over a long period of time, the occurrence of systemic side effects (e.g. renal, hepatic or gastrointestinal side effects, systemic hypersensitivity reactions), as you may experience after systemic use of medicines containing diclofenac, cannot be ruled out. Propyl-4-hydroxybenzoate and methyl-4-hydroxybenzoate can cause hypersensitivity reactions, including delayed reactions.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW SHOULD DICLOFENAC AL BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the tube after "use by" or "exp.". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Do not refrigerate or freeze. Do not use for more than 6 months after opening. Do not use this medicine if you notice any visible signs of deterioration. Never dispose of medicines via wastewater (e.g. not via the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer use it. This helps to protect the environment. For more information, see www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Diclofenac AL Pain Gel 10 mg/g, gel contains

The active ingredient is: Diclofenac sodium. 1 g of gel contains 10 mg of diclofenac sodium. The other ingredients are: Propylene glycol, medium-chain triglycerides, carbomer 980, hypromellose, propyl-4-hydroxybenzoate (Ph.Eur.) (E 216), methyl-4-hydroxybenzoate (Ph.Eur.) (E 218), sodium hydroxide (to adjust the pH), purified water.

What Diclofenac AL Pain Gel 10 mg/g, gel looks like and contents of the pack

White, soft, homogeneous gel, with a slightly characteristic odour. Diclofenac AL Pain Gel 10 mg/g, gel is packaged in an aluminium tube with epoxy-phenol inner coating and closed with an aluminium membrane with a PE screw cap for 50 g of gel and with an HDPE screw cap for 100 g, 120 g and 150 g of gel. Diclofenac AL Pain Gel 10 mg/g, gel is available in packs of 50 g, 100 g, 120 g and 150 g of gel.

Pharmaceutical entrepreneur

Aliud Pharma GmbH
Gottlieb-Daimler-Str. 19
89150 Laichingen
info@aliud.de

Manufacturer

Laboratories Basi - Industria Farmaceutica, S.A.
Parque Industrial Manuel Lourenco Ferreira, lotes 8, 15 e 16
3450-232 Mortagua
Portugal

This package leaflet was last revised in November 2020.

Source: Information from the package leaflet
Status: 10/2021
Active ingredient: Diclofenac sodium. Areas of application: for adults for the local, symptomatic treatment of mild to moderate, acute muscle pain, pain from acute sprains, strains or bruises resulting from blunt trauma and for adolescents from 14 years of age for the local, symptomatic treatment of pain from acute sprains, strains or bruises resulting from blunt trauma.