CALMINEMED 140 mg Transdermal Patch

Зміст інструкції

1. Calminemed 140 mg medicated patch
   1. What is Calminemed and what is it used for
   2. What you need to know before using Calminemed
   3. How to use Calminemed
   4. Possible side effects
   5. How to store Calminemed
   6. Package contents and other information

Calminemed 140 mg medicated patch

Diclofenac epolamine

Read this leaflet carefully before you start to use this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want any further information or advice, ask your doctor or pharmacist.
• If you get any side effects, even if not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• Talk to your doctor if your symptoms do not improve or get worse after 7 days.

Contents of this leaflet:

• 1. What Calminemed is and what it is used for
• 2. What you need to know before you use Calminemed
• 3. How to use Calminemed
• 4. Possible side effects
• 5. How to store Calminemed
• 6. Contents of the pack and other information

1. What is Calminemed and what is it used for

It is indicated in adults and adolescents over 16 years of age.
Calminemed belongs to a group of medicines called non-steroidal anti-inflammatory drugs
(NSAIDs). NSAIDs reduce pain and inflammation.
Calminemed is to be used for the symptomatic local and short-term treatment of mild painful conditions affecting joints, muscles, tendons and ligaments.
Children and adolescents under 16 years of age
Calminemed should not be used in children and adolescents under 16 years of age, as the data
available on the efficacy and safety of this medicine are not sufficient.

2. What you need to know before using Calminemed

Do not use Calminemed:

• if you are allergic to diclofenac epolamine or to any of the other ingredients of Calminemed (listed in section 6)
• if you are allergic to any pain-relieving (analgesic) or anti-inflammatory (NSAID) drug
• if you suffer from asthma, breathing problems, skin rashes or runny nose, following the intake of acetylsalicylic acid (aspirin) or other NSAIDs
• if you have damaged skin, including oozing or infected areas, eczema, burns or wounds
• if you are entering the 6th month of pregnancy or if you have already passed it
• if you currently suffer from a stomach ulcer (peptic ulcer)

Warnings and precautions
Consult your doctor or pharmacist before using Calminemed if:

• you suffer from breathing problems (allergic rhinitis, nasal polyps, asthma, chronic bronchial diseases);
• you are affected by a disease of the kidneys, heart or liver;
• you have suffered in the past from stomach or duodenal ulcers;
• you suffer from or have suffered in the past from an inflammatory bowel disease;
• you are prone to bleeding episodes;
• you are in the first 6 months of pregnancy or if you are breastfeeding.

Other important information
To keep symptoms under control, always use the lowest effective dose of Calminemed and for the shortest
possible time.
Calminemed must be used with caution in elderly patients who may be more easily
subject to experiencing undesirable effects.
In order to minimize the occurrence of undesirable effects, it is recommended to use the lowest
effective dose and for the shortest possible time.
Do not use Calminemed together with other medicines containing diclofenac or with other non-steroidal anti-inflammatory drugs (NSAIDs).
Avoid exposure to direct sunlight or to a solarium for at least one day after
removing the patch, in order to reduce the risk of photosensitivity.
Be careful not to use occlusive bandages and to avoid dressings that do not allow the skin to breathe.
Stop using the patch and inform your doctor or pharmacist if a skin rash appears in
the application area of the patch or if you experience generalized episodes of sensitization
(hypersensitivity), in particular following prolonged treatment.

Children and adolescents
Do not use the patch in children and adolescents under the age of 16 years.

Elderly patients
In this case, proceed with greater caution in the use of Calminemed due to the possibility of
side effects occurring.

Patients with hepatic impairment or renal damage
If you suffer from liver or kidney problems, proceed with greater caution in the use of Calminemed due to the
possibility of side effects occurring.

Other medicines and CalminemedIf the patch is used correctly, the risk of interactions
with other medicines is very low. However, inform your doctor or pharmacist if you are using, have
recently used or may use any other medicine.

Pregnancy
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine. You should not
use Calminemed if you are entering the 6th month of pregnancy or if you have already passed it, as this
could harm the fetus or cause problems during childbirth.

Breastfeeding
During breastfeeding, mothers should not apply the patch to the breast, nor elsewhere on large
areas of the skin or for a prolonged period of time.

Fertility
As with other NSAIDs, the use of diclofenac may impair female fertility and should therefore be avoided if you are planning a pregnancy. In women who have difficulty conceiving or
who are undergoing investigations related to infertility, the use of diclofenac should be avoided.

Driving and operating machinery
Calminemed does not impair the ability to drive vehicles and operate machinery.

Calminemed contains

• Propylene glycol, which may cause skin irritation.
• Methyl-parahydroxybenzoate and propyl-parahydroxybenzoate which may cause allergic reactions (including delayed reactions).

3. How to use Calminemed

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and adolescents over 16 years of age
Apply one patch per day for a maximum of 7 days. If you do not notice any improvement or your symptoms worsen during the recommended treatment period, you should consult your doctor.
This medicated patch should not be used in children and adolescents under 16 years of age, as sufficient data on the efficacy and safety of this medicine are not available.

Method of administration
Instructions for use for packs of 2, 5 and 10 medicated patches:
a) Cut the top of the resealable pouch
containing the medicated patches, following the
dashed line.

b) Remove one patch and carefully reseal
using the airtight closure by pressing on the
zipper.

c) Remove the plastic layer protecting
the adhesive side of the medicated patch.
d) Apply the medicated patch to the swollen skin area or where you feel pain.
Instructions for use for the 7-patch pack only:
a) Cut the top of the non-resealable pouch
following the dashed line and remove the
medicated patch.

b) Remove the plastic layer protecting
the adhesive side of the medicated patch.
c) Apply the medicated patch to the swollen skin area or where you feel pain.
If necessary, it can be held in place with a wide-mesh gauze bandage, avoiding the use of non-breathable bandages, or you can use the tubular elastic net provided in the pack.
The medicated patch must only be applied to intact and undamaged skin, avoiding application to lesions or open wounds. The patch should not be used while bathing or showering.
The medicated patch must be used whole, for the shortest possible time, as stated in the instructions for use.

If you forget to use Calminemed
Do not use more than one patch at a time. If you would like more information, please contact your doctor or pharmacist.

4. Possible side effects

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

Some uncommon and very rare side effects can be serious
If you experience any of the following signs of allergy, STOP using Calminemed and
seek immediate medical or pharmacist advice:

• Swelling of the lips, eyes or tongue, wheezing or asthma attack, which are signs of a serious allergic reaction
• Burning or irritation in the area where the patch has been applied. In general, side effects affect the application site.

Common side effects(may affect up to 1 to 10 users out of 100)
Skin reactions: skin rashes, dermatitis, redness and swelling of the skin, itching,

Other side effects
Uncommon, rare and very rare: skin rashes with blister or bubble formation, dry skin,
allergic reaction even after exposure of the skin to sunlight or tanning lamps
(photosensitivity), urticaria.
If the medicated patches are used correctly, the risk of side effects is very low, while
prolonged periods of treatment or simultaneous use with other medicines containing
diclofenac, especially orally, do not exclude the risk of widespread side effects.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Calminemed

Keep this medicine out of sight and reach of children.
Do not store at a temperature above 30 °C.
Only for packs of 2, 5 and 10 patches: do not use this medicine after 3 months from the first opening
of the sachet. After removing the patch, make sure that the sachet is tightly closed.
Do not use this medicine after the expiry date which is stated on the sachet and on the packaging. The
expiry date refers to the last day of that month.
Do not throw away any patches, but dispose of them in accordance with local regulations
in force. Used patches must not be thrown into the toilet or into liquid waste disposal systems.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Package contents and other information

What Calminemed contains
The active ingredient is diclofenac epolamine. Each medicated patch contains a total of 180 mg of
diclofenac epolamine, corresponding to 140 mg of diclofenac sodium (1% w/w).
The other ingredients are gelatin, povidone (K90), sodium heparin, liquid sorbitol, kaolin, titanium
dioxide (E171), propylene glycol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), disodium edetate (E385), tartaric acid, aluminum glycinate, sodium carboxymethylcellulose, sodium
polyacrylate, 1,3-butylene glycol, polysorbate 80, fragrance (propylene glycol, benzyl salicylate, phenylethyl alcohol, alpha-amyl-cinnamaldehyde, hydroxycitronellal, phenylethyl phenylacetate, cinnamyl acetate,
benzyl acetate, terpineol, cinnamyl alcohol, cyclamen aldehyde), purified water and a non-woven polyester backing.

Description of the appearance of Calminemed and package contents
Each medicated patch consists of a dressing impregnated with a paste ranging in color from white to pale
yellow, with the adhesive layer protected by a removable transparent plastic backing.
Packs of 2, 5 or 10 medicated patches contain 1 or 2 resealable pouches, while the pack
of 7 patches contains 7 non-resealable pouches of 1 patch each.
Each package contains a tubular net.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
IBSA Farmaceutici Italia srl
Via Martiri di Cefalonia, 2
26900 Lodi, Italy

Manufacturer
Altergon Italia srl
Zona Industriale ASI
83040 Morra De Sanctis (Av), Italy

This medicinal product is authorised in the following Member States of the European Economic Area with
the following denominations:
Belgium Flalgo/Weavor
Czech Republic Flalgo
Hungary Flectorin
Italy Calminemed
Slovak Republic Flectopar
Spain Flectormed