Patient leaflet - Zentarol 2.32% gel
1. WHAT RALGEFLAM IS AND WHAT IT IS USED FOR
The name of this medicine is Ralgeflam Muscle & Joint Pain Relief Max Strength 2.32% Gel (called Ralgeflam throughout this leaflet).
Ralgeflam contains the active substance diclofenac which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
For adults and adolescents aged 14 years and over
For the short-term local, symptomatic treatment of mild to moderate pain in acute strains, sprains or contusions following blunt trauma.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE RALGEFLAM
DO NOT use Ralgeflam:
- if you are allergic to diclofenac or any of the other ingredients of this medicine listed in section 6.
- if you have ever developed breathing problems (asthma, bronchospasm), hives, runny nose, or swelling of the face or tongue after taking/using acetylsalicylic acid or another non-steroidal anti-inflammatory drugs (e.g. ibuprofen);
- on open injuries, inflammations or infections of the skin as well as on eczema or mucous membranes;
- if you are in the last 3 months of pregnancy “see Pregnancy”;
- in children and adolescents under 14 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before using Ralgeflam:
If you are more likely to get asthma attacks (so-called analgesic intolerance / analgesic asthma), local skin or mucous membrane swelling (so-called Quincke oedema) or hives than other patients.
If you suffer from asthma, hay fever, swelling of the nasal membrane (so-called nasal polyps) or chronic obstructive pulmonary disease, chronic respiratory tract infections (particularly associated with hay fever-like symptoms) or hypersensitivity to other painkillers and anti-rheumatic medicines of any kind.
In these patients, Ralgeflam may only be used under certain precautions (emergency preparedness) and direct medical supervision. The same applies for patients who are also allergic to other substances e.g. with skin reactions, itching or hives.
When Ralgeflam is applied to a large area of skin and over a prolonged period, the possibility of side-effects that affect your internal body systems due to the application of Ralgeflam cannot be excluded. The gel should therefore be used with caution by patients with reduced kidney function, reduced heart function or reduced liver function as well as patients with active peptic ulcers in the stomach or duodenum.
Apply Ralgeflam only to intact, not diseased or injured skin. Avoid contact with eyes and mucous membranes. Do not swallow the gel.
After applying the gel on the skin you can use a permeable (non-occlusive) bandage but allow the gel to dry on the skin for a few minutes. Do not use an airtight occlusive dressing.
If the symptoms worsen or do not improve after 3 - 5 days, consult a doctor.
The use of Ralgeflam should be discontinued if you develop a skin rash.
If you are exposed to direct sunlight or artificial sun there is a risk of skin reactions. You should avoid sunlight or artificial sun during treatment and for two weeks after stopping treatment.
Precautions should be taken to prevent children from touching the area to which the gel is applied.
Do not smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product buildup but not totally remove it.
Children and adolescents
Do not use this medicine in children and adolescents under 14 years of age. Other medicines and Ralgeflam
Tell your doctor or pharmacist if you are taking, have recently taken or might take/use any other medicines.
There are currently no known interactions with other medicines following application of Ralgeflam to the skin as instructed.
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.
Pregnancy
Do not use Ralgeflam if you are in the last 3 months of pregnancy. You should not use Ralgeflam during the first 6 months of pregnancy unless clearly necessary and advised by your doctor. If you need treatment during this period, the lowest dose for the shortest time possible should be used.
Oral forms (e.g. tablets) with the active ingredient diclofenac can cause adverse effects in your unborn baby. It is not known if the same risk applies to Ralgeflam when it is used on the skin.
Breast-feeding
Ralgeflam should only be used under medical advice during breast-feeding as diclofenac passes into breast milk in small amounts. Do not apply Ralgeflam on the breasts if you are a nursing mother nor elsewhere on large areas of skin or for a prolonged period of time.
Driving and using machines
Ralgeflam has no or negligible influence on the ability to drive or to use machines.
Ralgeflam contains Propylene glycol (E1520)
This medicine contains 54 mg propylene glycol in 1 g of gel.
Ralgeflam contains Butylhydroxytoluene (E321)
Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.
Ralgeflam contains fragrances
This medicine contains fragrance with benzyl alcohol (0.15 mg/g, E1519), citral, citronellol, coumarin, eugenol, farnesol, geraniol, limonene and linalool which may cause allergic reactions.
In addition, benzyl alcohol may cause mild local irritation.
3. HOW TO USE RALGEFLAM
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you. Check with your doctor or pharmacist if you are not sure.
Adults and adolescents 14 years and over
Ralgeflam is used 2 times a day (preferably morning and evening).
Depending on the size of the affected site to be treated, apply a cherry to walnut sized quantity, corresponding to 1 - 4 g of gel as required.
The maximum daily dose is 8 g of gel.
Elderly patients
No special dose adjustment is necessary. If you are elderly, you should pay special attention to side effects and, if necessary, consult a doctor or pharmacist.
Impaired kidney or liver function
No dose reduction is necessary.
Use in children and adolescents (under 14 years)
Do not use this medicine in children and adolescents under 14 years of age (see section 2 “Do not use Ralgeflam”)
Before using for the first time, open as follows:
- Unscrew the cap from the tube. To open the safety seal of the tube, reverse the cap and engage with the nozzle. Do not use scissors or other sharp objects!
- Twist and remove the plastic seal from the tube. Use the gel as described in this leaflet. Do not use if the seal is broken.
How to apply:
Ralgeflam is for cutaneous use only.
The gel is applied to the affected parts of the body thinly and gently rubbed into the skin. Afterwards, the hands should be wiped with a paper towel and then washed, unless the hands are the area to be treated.
If too much gel is accidently applied, the excess gel should be wiped with a paper towel.
The paper towel should be disposed in the household waste to prevent unused product reaching the aquatic environment.
Before applying a bandage, the gel should be left to dry for a few minutes on the skin.
Duration of treatment:
The duration of use depends on the symptoms and the underlying disease. Ralgeflam should not be used longer than 1 week without medical advice.
If symptoms worsen or do not improve after 3 – 5 days a doctor should be consulted.
If you use more Ralgeflam than you should
An overdose is unlikely to happen if you use more Ralgeflam than you should, because the absorption into the blood stream is low when used on the skin. If the recommended dose is significantly exceeded when used on the skin, the gel should be removed and washed off with water.
If you accidentally swallow Ralgeflam, contact your doctor who decides on the appropriate measures.
If you forget to use Ralgeflam
Do not use a double dose to make up for a forgotten application.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some rare and very rare side effects may be serious.
If you experience any of the following signs of allergy, stop using Ralgeflam and tell a doctor or pharmacist immediately:
- Skin rash with blisters; hives (may affect up to 1 in 1,000 people),
- Wheezing, shortness of breath or feeling of tightness in the chest (asthma) (may affect up to 1 in 10,000 people).
- Swelling of the face, lips, tongue or throat. (may affect up to 1 in 10,000 people).
Other side effects are possible:
Common side effects (may affect up to 1 in 10 people):
Skin rash, itching, reddening, eczema, dermatitis (inflammation of the skin) including contact dermatitis.
Uncommon side effects (may affect up to 1 in 100 people):
Scaling, dehydration of the skin, swelling (oedema)
Very rare side effects (may affect up 1 in 10,000 people)
Pustular rash, gastrointestinal complaints, hypersensitivity reactions (including hives), sensitivity to light with appearance of skin reactions after exposure to sunlight.
Not known side effects (frequency cannot be estimated from the available data). Burning sensation at the application site, dry skin
When Ralgeflam is applied to a large area of skin and over a prolonged period, the possibility of side-effects that affect your internal body systems (e.g. kidneys, liver or gastrointestinal tract or hypersensitivity reactions) - as they may occur after oral administration of diclofenac-containing medicines cannot be completely excluded.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE RALGEFLAM
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 blister pack and the carton. The expiry date refers to the last day of that month.
Store in the original tube in order to protect from light.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. Please, do not apply the ointment shortly before taking a shower or bath. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Ralgeflam contains:
- The active substance is diclofenac (as diclofenac diethylamine).
- 1 g of gel contains 23.2 mg diclofenac diethylamine corresponding to 20 mg diclofenac sodium.
- The other ingredients are: isopropyl alcohol, propylene glycol (E1520), cocoyl caprylocaprate, liquid paraffin, carbomer, macrogol cetostearyl ether, diethylamine, oleic acid (E570), butylhydroxytoluene (E321), fragrance (contains camphor, eucalyptol, ambroxide, citronellol, geraniol, benzyl alcohol (E1519), linalool, limonene, citral, farnesol, coumarin, eugenol), purified water.
What Ralgeflam looks like and contents of the pack:
White to almost white, homogeneous cream like gel, packed in aluminium laminated tubes, closed with PE seal and PP screw caps.
The product comes in packs of 30 g or 50 g. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva Pharma UK Limited
12 New Fetter Lane,
London, EC4A 1JP,
United Kingdom
Manufacturer
Merckle GmbH,
Graf-Arco-Str. 3,
89079 Ulm,
Germany