The Danish Health and Medicines Authority warns against taking the weight-loss products Slimex 15 and Slimex 15 New Formula that are sold on the internet. The weight-loss products contain sibutramine that may cause serious side effects.
If you are taking Slimex 15 or Slimex 15 New Formula, we advise you to stop taking the product immediately and to contact your doctor. Please return any unused products to the nearest pharmacy for destruction.
The weight-loss product Slimex 15 is available in the form of yellow or orange capsules, while Slimex 15 New Formula is available in the form of white tablets:
Slimex 15 (yellow capsule): Our analysis shows that the product contains sibutramine, but this does not appear from the package.
Slimex 15 (orange capsule): It appears from the package that the product contains sibutramine (”Sibutramine Hydrochloride Monohydrate”).
Slimex 15 New Formula (white tablet): Our analysis shows that the product contains sibutramine, but this does not appear from the package.
Risk of serious side effects
Sibutramine affects neurotransmitters in the brain, which suppresses appetite. The adverse reactions from sibutramine could turn out to be very serious and may show as a faster heart rate, hypertension, hot flush, constipation, nausea, trouble sleeping, headache, anxiety, perspiration and taste perversion. All medicines containing sibutramine were withdrawn from the market in the autumn of 2010 due to the risk of serious cardiovascular adverse reactions and brain haemorrhages.
We generally urge people to be careful when they buy medicines on the internet. We recommend that you contact your doctor before you buy any medicines on the Internet.
Photos of Slimex 15
Slimex 15 (Yellow capsule)
Slimex 15 (Orange capsule)
Slimex 15 New Formula (White tablet)
Sandoz d.o.o., the marketing authorisation holder for Propranolol Sandoz 40 mg tablets (propranolol) has notified the agency for Medicinal Products and Medical Devices (HALMED) on the expected shortage of this medicinal product on the Croatian market. The shortage is due to manufacturing or purchase problems of the active substance.
More information is accessible under the link below.
Terveyskaista Oy´s Sininen Uni Jet Lag preparation classed as a medicinal product 29 September 2011
A decision issued by the Finnish Medicines Agency (Fimea) on 29 September 2011 classifies the Sininen Uni Jet Lag melatonin preparation as a medicinal product. Fimea has ordered the decision be enforced with immediate effect for reasons of public interest under Section 31, Paragraph 2 of the Administrative Judicial Procedure Act.
The recommended dose for the Sininen Uni Jet Lag preparation is 1-2 tablets (a single tablet contains 2mg of melatonin). An equivalent product (1 tablet daily), manufactured by Circadin and subject to a European marketing authorization, is currently available as a prescription-only medicine. In view of the safety information displayed on the Circadin packaging, the information provided in conjunction with the Sininen Uni Jet Lag product can be considered defective and misleading.
According to the decision issued by Fimea, Sininen Uni Jet Lag must be classified as a medicinal product on the basis of its composition, mechanism of action, characteristics and intended use.
The sale and marketing of a medicinal product without a marketing authorisation is prohibited under Section 20 of the Medicines Act.
Fimea has previously, on 21 December 2009, classified the Sininen Uni nutritional supplement as a medicinal product. This decision was ordered to be enforced with immediate effect. The product subject to the decision also contained 2mg of melatonin per tablet. A Helsinki Administrative Court ruling rejected an appeal against the Fimea decision on 29 August 2011. The ruling is not yet final. The Helsinki Administrative Court and the Supreme Administrative Court have confirmed that Fimea may enforce the decision prior to it being made final. Fimea accordingly ordered the sale and marketing of the product to be halted by 8 February 2010 and the sales prohibition remains in force in accordance with the Court’s decision.
Terveyskaista Oy has subsequently begun marketing an equivalent product as a nutritional supplement. Fimea has notified the company that they must discontinue the sale and marketing of the Sininen Uni Jet Lag product by 1 November 2011.
Terveyskaista Oy has indicated to Fimea its intention of challenging this decision by appeal. The company can also simultaneously appeal Fimea’s enforcement decision. In the event that the Court finds in favour of the appellant, the marketing of the product may continue. Otherwise the marketing of this product must be discontinued.
For further information, please contact:
Kristiina Pellas, Senior Pharmaceutical Inspector, tel: +358 (0)9 4733 4336
Tuula Nousu, Legal Counsel, tel: +358 (0)9 4733 4219
E-mail address: email@example.com.
Updated principles for compiling the list of substitutable medicinal productsThe National Agency for Medicines is compiling a list of products that contain the same quantity of the same active agent and are biologically equivalent. The reform of the Medicines Act and the experience gained during three years of medicinal product substitution have been taken into account in updating the principles for compiling the list of substitutable medicinal products.Wider definition of active agentAccording to the new definition of active agent, different salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives of the same agent may, on certain conditions, be considered as the same active agent and thus mutually substitutable, provided they otherwise meet the criteria for substitutability.New pharmaceutical forms accepted as substitutableIn applications for marketing authorisation, different pharmaceutical forms releasing the medicinal substance immediately (i.e. different forms of tablets and capsules) have been considered equivalent for several years. This principle will now also be applied to medicinal product substitution. New substitutable pharmaceutical forms have been included: modified-release tablets, modified-release capsules, ointments and shampoos. Modified-release tablets and capsules may be mutually substitutable, as may gastro-resistant tablets and capsules, provided they otherwise meet the criteria for equivalence.Antipsychotics and medication used to treat dementia are now also considered to be substitutable. Parallel distribution of centrally authorised products, corresponding to parallel import, has been added to the terminology.For further details, see Criteria for compiling the list of substitutable medicinal productsMore information:Professor Olavi Tokola, Head of Department, tel. +358 9 4733 4227, firstname.lastname@example.orgJussi Holmalahti, Head of Section, tel. +358 9 4733 4239, email@example.com
The sale of Nimed, an anti-inflammatory analgesic, is temporarily suspended due to its adverse liver effectsA decision was made on 15.3.2002 by the National Agency for Medicines in Finland together with Aventis Pharma to suspend the distribution, sale and any other supply for consumption of tablets and granules of Nimed; the suspension will come into force on 18.3.2002. The marketing authorisation of all preparations of Nimed will nevertheless remain in force. The decision is due to the severe undesirable effects on the liver associated with the use of Nimed. A review by the National Agency for Medicines and the marketing authorisation holder Aventis Pharma of the situation is currently under way.The active substance contained in Nimed is nimesulide of the anti-inflammatory analgesic group. Marketing authorisation for it as a prescription drug was approved in Finland in August 1997 and it was introduced on to the market in January 1998. Nimed is indicated for the treatment of pain associated with arthrosis, various transient pains, dysmenorrhoea and fever.By 13.3. 2002, the adverse effects register of the National Agency for Medicines had received a total of 109 reports on adverse effects associated with the use of Nimed, 66 of which were on liver effects. The reports most frequently involved symptomfree elevation of liver enzymes, but cases of hepatitis and isolated cases of reactions necessitating a liver transplant were also reported. The first report of a fatal liver effect which is suspected to be associated with the use of Nimed was received by the National Agency for Medicines on 11.3.2002. The patient was also using other drugs and the case is under review at present.The use of Nimed is not prohibited, but the patients are requested to contact the doctor in charge of their treatment as necessary to ensure that they receive appropriate medication. The patient should also contact his or her doctor if new symptoms possibly indicative of liver dysfunction occur such as general malaise, nausea, lack of appetite, abdominal pain or jaundice.Further information available fromErkki Palva, Professor, Research Director, telephone (09) 4733 4288, 050 552 1154 firstname.lastname@example.orgMarja-Leena Nurminen, Senior Medical Officer, telephone (09) 4733 4294 email@example.comRiitta Tokola, Senior Medical Officer, telephone (09) 4733 4331 firstname.lastname@example.orgHannu Kokki, Senior Medical Officer, telephone (09) 4733 4375 email@example.com